Method of performing a minimally invasive procedure on a hip joint of a patient to relieve femoral acetabular impingement

ABSTRACT

A method of performing a minimally invasive procedure on a hip joint of a patient to relieve a femoral acetabular impingement. An access device is placed through skin of the patient to provide minimally invasive access to a target volume of material that creates the femoral acetabular impingement. A cutting accessory is placed into the access device to remove material and relieve the femoral acetabular impingement. A tracking and control system establishes a virtual boundary that defines the target volume of material that creates the femoral acetabular impingement, tracks a position of the cutting accessory relative to the virtual boundary, and 
     controls movement of the cutting accessory so that cutting is substantially maintained within the virtual boundary.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/600,888 filed on Aug. 31, 2012, which claims priority to and all thebenefits of U.S. Provisional Patent Application No. 61/530,614 filed onSep. 2, 2011 and U.S. Provisional Patent Application No. 61/662,070filed on Jun. 20, 2012, all of which are incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates generally to hand-held surgicalinstruments, systems for tracking and controlling hand-held surgicalinstruments, and methods of use. The tracking and control system is usedto keep a working part of the instrument in a desired relationship to aboundary. The system controls the position of a cutting accessoryintegral with the instrument when the accessory is applied to tissueduring a medical/surgical procedure.

BACKGROUND OF THE INVENTION

Tracking systems (also known as navigation systems) assist surgeonsduring surgeries that require the precise locating of instruments. Suchsurgeries include neurosurgery and orthopedic surgery. The trackingsystem tracks the position and orientation of an instrument during theprocedure and often displays the position and/or orientation of theinstrument on a monitor in conjunction with a preoperative image or anintraoperative image of the patient (preoperative images are typicallyprepared by MRI or CT scans, while intraoperative images may be preparedusing a fluoroscope, low level x-ray or any similar device).Alternatively, some systems are image-less in which the patient'sanatomy is instead registered and mathematically fitted with ananatomical model.

Prior art tracking systems typically employ a camera that detects atracking device located on the instrument. The tracking device has aplurality of optical markers such as light emitting diodes (LEDs) todetermine the position and orientation of the instrument. The positionof the instrument usually correlates to the coordinates of a working endof the instrument in three-dimensional space, the x, y, z or Cartesiancoordinates, relative to the camera. The orientation of the instrumentmeans the pitch, roll, and yaw of the instrument. When both the positionand the orientation of the instrument are defined, the relative positionof that instrument is known to the tracking system.

Orthopedic surgeons have been using tracking systems for some time toassist in properly locating and positioning cutting jigs. Cutting jigsare used to resect bone for the purpose of preparing joints to acceptreplacement implants. The time required to position and secure a cuttingjig can appreciably add to the overall time required to perform a jointreplacement surgical procedure. It should be appreciated that thecutting jig must be accurately positioned. Imprecise positioning of acutting jig can contribute to a less than ideal surgical outcome. As aresult, there has been a movement to eliminate the use of cutting jigs.Instead, surgeons would rely solely on tracking the instrument to ensurethat the cutting portion of the instrument does not stray beyond apredefined boundary.

In such tracking systems both the instrument and the material being cutare outfitted with trackers such that the tracking system can track boththe position and orientation of the instrument and the material beingcut such as a bone. The instrument is held by a robot or otherarticulation mechanism that provides some form of mechanical constraintto movement. This constraint limits the movement of the instrument towithin a predefined boundary. If the instrument strays beyond thepredefined boundary, a control is sent to the instrument to stopcutting. Such systems are shown in U.S. Pat. No. 5,408,409 to Glassmanet al.

It has also been proposed in the prior art that the instrument be usedfree hand without the aid of cutting jig, guide arm or otherconstraining mechanism to establish the location to which the cuttingimplement at the end of the instrument is applied. See, for example,U.S. Pat. No. 6,757,582 to Brisson et al.

SUMMARY AND ADVANTAGES

The present invention provides an instrument for treating tissue duringa medical procedure. The instrument comprises a hand-held portion forbeing manually supported and moved by a user. A working portion ismovably coupled to the hand-held portion. A plurality of actuators areoperatively coupled to the working portion for moving the workingportion in a plurality of degrees of freedom relative to the hand-heldportion. A tracking device is attached to the hand-held portion fortracking the instrument. A drive mechanism is coupled to the workingportion for rotating the working portion about a rotational axis. Thedrive mechanism moves in at least one degree of freedom relative to thehand-held portion.

The present invention also provides an instrument for treating tissueduring a medical procedure, as described in this paragraph. Theinstrument comprises a hand-held portion for being manually supportedand moved by a user. A working portion is movably coupled to thehand-held portion and includes a distal tip. A plurality of actuatorsare operatively coupled to the working portion for moving the workingportion in a plurality of degrees of freedom relative to the hand-heldportion. A tracking device is attached to the hand-held portion fortracking the instrument. The distal tip of the working portion iscapable of a total displacement of at least 0.2 inches (0.508 cm) ineach of the plurality of degrees of freedom.

The present invention also provides a method for treating tissue duringa medical procedure using an instrument having a hand-held portion, aworking portion, a plurality of actuators for moving the working portionin a plurality of degrees of freedom relative to the hand-held portion,a plurality of sensors for sensing positions of the working portionrelative to the hand-held portion, and a control system for controllingthe instrument. The method comprises the steps of: manually supportingand moving the hand-held portion during the medical procedure to treatthe tissue of a patient with the working portion; and operating thecontrol system so that the control system establishes a home position ofthe working portion relative to the hand-held portion and tracksdeviation of the working portion from the home position as the workingportion moves in one or more of the plurality of degrees of freedomrelative to the hand-held portion in order to maintain a desiredrelationship to a virtual boundary associated with the tissue during themedical procedure.

The present invention also provides a method for treating tissue duringa medical procedure using an instrument, as described in this paragraph.The instrument has a hand-held portion, a working portion, a pluralityof actuators for moving the working portion in a plurality of degrees offreedom relative to the hand-held portion, a plurality of sensors forsensing positions of the working portion relative to the hand-heldportion, and a control system for controlling the instrument. The methodcomprises the steps of: manually grasping and moving the hand-heldportion during the medical procedure to treat the tissue of a patientwith the working portion; and operating the control system so that thecontrol system establishes a home position of the working portionrelative to the hand-held portion and tracks deviation of the workingportion from the home position as the working portion moves in one ormore of the plurality of degrees of freedom relative to the hand-heldportion in order to maintain a desired relationship to a virtualboundary associated with the tissue during the medical procedure. Thecontrol system controls a cutting speed of the working portion based onthe deviation.

The present invention also provides an instrument for treating tissueduring a medical procedure, as described in this paragraph. Theinstrument comprises a hand-held portion for being manually supportedand moved by a user. A drive assembly is movably coupled to thehand-held portion and supports a working portion. A plurality ofactuators are operatively coupled to the working portion for moving theworking portion in a plurality of degrees of freedom relative to thehand-held portion. A tracking device is mounted to the hand-held portionfor tracking the instrument during the medical procedure. The driveassembly supports one of the actuators and is movable by at leastanother of the actuators in at least one degree of freedom relative tothe hand-held portion.

The present invention also provides an instrument for treating tissueduring a medical procedure, as described in this paragraph. Theinstrument comprises a hand-held portion for being manually supportedand moved by a user. A working portion is movably coupled to thehand-held portion. A plurality of actuators are operatively coupled tothe working portion for moving the working portion in a plurality ofdegrees of freedom relative to the hand-held portion. A tracking deviceis attached to the hand-held portion for tracking the instrument. Atleast one adjustment mechanism is disposed between the actuators and theworking portion for transmitting movement from the actuators to theworking portion.

The present invention also provides an instrument for treating tissueduring a medical procedure, as described in this paragraph. Theinstrument comprises a hand-held portion for being manually supportedand moved by a user. A working portion is movably coupled to thehand-held portion. A plurality of actuators are operatively coupled tothe working portion for moving the working portion in a plurality ofdegrees of freedom relative to the hand-held portion. A tracking deviceis mounted to the hand-held portion for tracking the instrument duringthe medical procedure. A gimbal supports movement of the working portionin at least two of the degrees of freedom relative to the hand-heldportion.

The present invention also provides an instrument for treating tissueduring a medical procedure, as described in this paragraph. Theinstrument comprises a hand-held portion for being manually supportedand moved by a user. A working portion is movably coupled to thehand-held portion. A plurality of actuators are operatively coupled tothe working portion for moving the working portion in a plurality ofdegrees of freedom relative to the hand-held portion. A drive motor issupported by the hand-held portion and includes a drive shaft coupled tothe working portion for rotating the working portion about a cuttingaxis. A tracking device is mounted to the hand-held portion for trackingthe instrument during the medical procedure. One of the actuatorsincludes a motor having a hollow rotor that rotatably receives the driveshaft therein such that the drive shaft of the drive motor rotateswithin the hollow rotor and relative to the hollow rotor so as torotatably drive the working portion.

The present invention also provides an instrument for treating tissueduring a medical procedure, as described in this paragraph. Theinstrument comprises a hand-held portion for being manually supportedand moved by a user; a cutting accessory movably coupled to thehand-held portion; a plurality of actuators operatively coupled to thecutting accessory for moving the cutting accessory in a plurality ofdegrees of freedom relative to the hand-held portion, the plurality ofactuators including an axial actuator for translating the cuttingaccessory along an axis; a drive motor including a drive shaft forrotating the cutting accessory about a cutting axis; a tracking devicemounted to the hand-held portion for tracking the instrument during themedical procedure; and a collet assembly rotatably coupling the driveshaft to the cutting accessory so that the cutting accessory rotatesabout the cutting axis upon rotation of the drive shaft, the colletassembly configured to release the cutting accessory in response toactuation of the axial actuator beyond a predefined limit of actuation.

The present invention also provides an instrument for treating tissueduring a medical procedure, as described in this paragraph. Theinstrument comprises a hand-held portion for being manually supportedand moved by a user. A rotating cutting accessory is movably coupled tothe hand-held portion. A plurality of actuators are operatively coupledto the cutting accessory for moving the rotating cutting accessory in aplurality of degrees of freedom relative to the hand-held portion. Atracking device is attached to the hand-held portion for tracking theinstrument. A sleeve at least partially covers the cutting accessory andmoves with the cutting accessory in each of the plurality of degrees offreedom. The cutting accessory is configured to rotate within the sleeveduring the medical procedure.

The present invention also provides a system for treating tissue duringa medical procedure. The system comprises an instrument adapted to bemanually supported and moved by a user. The instrument includes ahand-held portion. A working portion is movably coupled to the hand-heldportion. A plurality of actuators are operatively coupled to the workingportion for moving the working portion in a plurality of degrees offreedom relative to the hand-held portion. A tracking device is attachedto the hand-held portion for tracking the instrument. The systemincludes a navigation system for determining a position of the workingportion relative to a virtual boundary associated with the tissue beingtreated. A control system is in communication with the actuators and isconfigured to control the actuators to actively position the workingportion at the boundary while the user moves the hand-held portionrelative to the boundary such that the working portion is substantiallymaintained at the boundary independent of the movement of the hand-heldportion.

The present invention also provides a system for treating tissue duringa medical procedure, as described in this paragraph. An instrument isadapted to be manually supported and moved by a user. The instrumentincludes a hand-held portion. A working portion is movably coupled tothe hand-held portion. A plurality of actuators are operatively coupledto the working portion for moving the working portion in a plurality ofdegrees of freedom relative to the hand-held portion. A tracking deviceis attached to the hand-held portion for tracking the instrument. Thesystem includes a navigation system for determining a position of theworking portion relative to a target volume of the tissue to be removed.A control system is in communication with the actuators and isconfigured to control the actuators to move the working portion relativeto the hand-held portion such that the working portion autonomouslyfollows a path defined in the control system to remove the target volumeof material while the user substantially maintains the hand-held portionin a gross position relative to the target volume during the medicalprocedure.

The present invention also provides a system for treating tissue duringa medical procedure, as described in this paragraph. The systemcomprises an instrument adapted to be manually supported and moved by auser. The instrument includes a hand-held portion, a working portionmovably coupled to the hand-held portion, a plurality of actuatorsoperatively coupled to the working portion for moving the workingportion in a plurality of degrees of freedom relative to the hand-heldportion, and a tracking device attached to the hand-held portion fortracking the instrument. The system includes a navigation system fordetermining a position of the working portion relative to a virtualboundary associated with the tissue being treated. A display is incommunication with the navigation system for indicating the position ofthe working portion relative to the virtual boundary. A control systemis in communication with the actuators to control the actuators to movethe working portion relative to the hand-held portion. The controlsystem is configured to establish a home position of the working portionrelative to the hand-held portion and track deviation of the workingportion from the home position as the working portion moves in one ormore of the plurality of degrees of freedom relative to the hand-heldportion in order to maintain a desired relationship to the virtualboundary during the medical procedure. The display indicates thedeviation of the working portion relative to the home position.

The present invention also provides a system for treating tissue duringa medical procedure, as described in this paragraph. The systemcomprises an instrument adapted to be manually supported and moved by auser. The instrument includes a hand-held portion, a working portionmovably coupled to the hand-held portion, a plurality of actuatorsoperatively coupled to the working portion for moving the workingportion in a plurality of degrees of freedom relative to the hand-heldportion, and a tracking device attached to the hand-held portion fortracking the instrument. The system includes a navigation system fordetermining a position of the working portion relative to a virtualboundary associated with the tissue being treated. A display is incommunication with the navigation system for indicating the position ofthe working portion relative to the virtual boundary. A control systemis in communication with the actuators to control the actuators to movethe working portion relative to the hand-held portion. The controlsystem is configured to control the display to change a resolution ofthe display as the working portion approaches the virtual boundary.

The present invention also provides a method for performing a spinalfusion procedure on a patient's spine. The method comprises:establishing a virtual boundary associated with the patient's spine;providing access through skin to the patient's spine; manually holdingan instrument having a hand-held portion, a cutting accessory, aplurality of actuators for moving the cutting accessory in a pluralityof degrees of freedom relative to the hand-held portion, and a trackingdevice; operating a tracking and control system for the instrument totrack movement of the cutting accessory relative to the virtualboundary; moving the cutting accessory through the incision in the skin;cutting away material from the patient's spine wherein the tracking andcontrol system controls the actuators to move the cutting accessoryrelative to the hand-held portion so that the cutting accessory issubstantially maintained in a desired relationship to the boundaryduring cutting; and fitting an implant into the patient's spine aftercutting away material from the patient's spine.

The present invention also provides a method for performing a procedureon a patient's hip. The method comprises: placing an access devicethrough skin of the patient to provide minimally invasive access to atarget volume of material that creates a femoral acetabular impingement;manually grasping and supporting an instrument to place a cuttingaccessory into the access device; removing material with the cuttingaccessory to relieve the femoral acetabular impingement while manuallygrasping and supporting the instrument. A tracking and control system isoperated to: establishing a virtual boundary that defines the targetvolume of material that creates the femoral acetabular impingement;track a position of the cutting accessory relative to the virtualboundary; and control movement of the cutting accessory longitudinallyalong the rotational axis so that cutting is substantially maintainedwithin the virtual boundary.

The present invention also provides a method for performing a procedureon a patient's knee. The method comprises: establishing a virtualboundary associated with the femur and tibia of the patient wherein thevirtual boundaries define a volume of material to be removed from thefemur and tibia to receive a graft; creating an access path through skinof the patient to provide access to the femur or tibia of the patient;manually holding an instrument having a hand-held portion, a cuttingaccessory, a plurality of actuators for moving the cutting accessory ina plurality of degrees of freedom relative to the hand-held portion, anda tracking device; operating a tracking and control system for theinstrument so that the tracking and control system tracks movement ofthe cutting accessory relative to the virtual boundaries; moving thecutting accessory through the access path to the femur or tibia; cuttingaway the volume of material from the femur and the tibia wherein thecutting occurs first through one of the femur or tibia to create a femuror tibia passage and with the cutting accessory positioned in the femuror tibia passage cutting then occurs in the other of the femur or tibiato form the other of the femur or tibia passage wherein the tracking andcontrol system controls the actuators to move the cutting accessoryrelative to the hand-held portion so that the cutting accessory issubstantially maintained in a desired relationship to the virtualboundaries during cutting in the tibia and the femur to remove thedefined volume of material; and placing a graft in the tibia passage andthe femur passage.

The present invention also provides a method for repairing a focaldefect in cartilage of a patient. The method comprises: establishing avirtual boundary associated with the focal defect in the cartilage ofthe patient wherein the virtual boundary defines a volume of material tobe removed around the focal defect; creating an access path through skinof the patient to provide access to the focal defect; manually holdingan instrument having a hand-held portion, a cutting accessory, aplurality of actuators for moving the cutting accessory in a pluralityof degrees of freedom relative to the hand-held portion, and a trackingdevice; operating a tracking and control system for the instrument sothat the tracking and control system tracks movement of the cuttingaccessory relative to the virtual boundary; moving the cutting accessorythrough the access path to the focal defect; and cutting away the volumeof material surrounding the focal defect. The control system controlsthe actuators to move the cutting accessory relative to the hand-heldportion so that the cutting accessory is substantially maintained in adesired relationship to the virtual boundary during cutting to removethe defined volume of material.

The present invention also provides a method for preparing bone toreceive an implant. The method comprises: establishing a virtualboundary associated with the bone of the patient wherein the virtualboundary defines a volume of bone to be removed to form an implantpocket shaped to receive an implant; providing access to the volume ofbone to be removed; manually holding an instrument having a hand-heldportion, a cutting accessory, a plurality of actuators for moving thecutting accessory in a plurality of degrees of freedom relative to thehand-held portion, and a tracking device; operating a tracking andcontrol system for the instrument so that the tracking and controlsystem tracks movement of the cutting accessory relative to the virtualboundary; moving the cutting accessory to the volume of bone to beremoved; and cutting away the volume of bone to form the implant pocket.The tracking and control system controls the actuators to move thecutting accessory relative to the hand-held portion so that the cuttingaccessory is substantially maintained in a desired relationship to thevirtual boundary during cutting so to remove the defined volume of bone.The method includes placing the implant in the implant pocket andsecuring the implant in position in the implant pocket.

Advantageously, the present invention provides for a compact design ofthe instrument, which beneficially allows the operator to easilymanipulate the instrument, while actuators of the instrument positionthe working portion in a plurality of degrees of freedom relative to thehand-held portion. This compact design also reduces visual interferencewith the tissue being operated upon. The compact design allows for thehand-held portion to be sized and shaped to be held and supported in thehand of a user.

The present invention also advantageously provides feedback to theoperator indicating relative position of the working portion of theinstrument to the virtual boundary. The operator can determine thelocation of the working portion relative to the virtual boundary byobserving deviation from the home position and/or speed attenuation ofthe working portion. The speed attenuation of the working portion canprovide visual and/or aural indication of position of the workingportion relative to the virtual boundary. Displays also provide feedbackregarding the position of the working portion.

The control system provides the ability to operate the instrument in avariety of modes and to perform a variety of procedures. For example,the instrument can be operated in an active mode, a passive mode, or anautonomous mode. The control system, for example, controls the actuatorsto position the working portion in the plurality of degrees of freedomrelative to the hand-held portion to maintain a desired relationship tothe virtual boundaries.

The variety of procedures that can be performed with the instrumentinclude, for example, sculpting, shaving, coring, boring, or any othermethod of removing tissue such as bone. The instrument can be used toremove tissue in spine, knee, hip, and other procedures. Theseprocedures may be open procedures or minimally invasive procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present invention will be readily appreciated as thesame becomes better understood by reference to the following detaileddescription when considered in connection with the accompanying drawingswherein:

FIG. 1 is a schematic view of a tracking and control system of thepresent invention;

FIG. 1A is an illustration of a work boundary;

FIGS. 2 and 2A are perspective views of a surgical instrument used inthe tracking and control system of FIG. 1;

FIG. 2A is a rear perspective view of the surgical instrument used inthe tracking and control system of FIG. 1;

FIGS. 3-5 are, respectively, front, top, and right views of the surgicalinstrument;

FIG. 6 is a top perspective view of the surgical instrument of FIG. 2with protective covers, display, and covers removed;

FIG. 7 is a front view of the surgical instrument from FIG. 6;

FIG. 8 is a cross-sectional view taken through the surgical instrumentfrom FIG. 7;

FIG. 9 is a top perspective view of an upper assembly of the surgicalinstrument of FIG. 6;

FIG. 10 is a perspective view of the upper assembly;

FIGS. 11-15 are front, top, bottom, left-side, and right-side views ofthe upper assembly;

FIG. 16 is a cross-sectional view taken along the line 16-16 in FIG. 12;

FIG. 17 is an exploded view of the upper assembly;

FIG. 17A is a cross-sectional view of the upper assembly taken generallyalong the line 17A-17A in FIG. 12;

FIG. 17B is a cross-sectional view of the upper assembly taken generallyalong the line 17B-17B in FIG. 11;

FIGS. 18-20 are back views of the upper assembly illustrating differentpitch positions of an end effector of the upper assembly;

FIGS. 21-23 are top views of the upper assembly illustrating differentyaw positions of the end effector;

FIGS. 24-27 are rear perspective views of the upper assemblyillustrating different yaw/pitch positions of the end effector;

FIG. 28 is a top perspective view of a handle assembly of the surgicalinstrument of FIG. 6;

FIG. 29 is a front and right perspective view of the handle assembly;

FIGS. 30-34 are front, top, bottom, left-side, and right-side views ofthe handle assembly;

FIG. 35 is a cross-sectional view taken along the line 35-35 in FIG. 31;

FIG. 35A is a cross-sectional view showing the sliding arrangement ofthe slider subassembly relative to the handle assembly;

FIG. 35B is a partial rear perspective view of the instrument with aportion of the handle cut away to show a nut and lead screw;

FIG. 36 is an exploded view of the handle assembly;

FIGS. 37-39 are top views of the handle assembly illustrating differentz-axis positions of a linear nut that drives the upper assembly;

FIG. 40 is a top perspective view of a slider subassembly of the upperassembly;

FIG. 41 is a rear perspective view of the slider subassembly;

FIG. 42 is an exploded view of the slider subassembly;

FIG. 43 is a bottom perspective view of the slider subassembly;

FIG. 43A is a top view of the slider subassembly;

FIG. 44 is a cross-sectional view of the slider subassembly taken alongthe line 44-44 in FIG. 43A;

FIG. 45 is a cross-sectional view of the slider subassembly taken alongthe line 45-45 in FIG. 43A;

FIG. 46 is a top perspective view of the handle assembly with portionsremoved to illustrate a path for wires;

FIG. 47 is a top view of the handle assembly with portions removed;

FIG. 48 is a right view of the handle assembly with portions removed;

FIGS. 49 and 50 are perspective cross-sectional views taken along thelines 49-49 in FIG. 47 and illustrating additional paths for wires;

FIG. 51 is a perspective view of the handle assembly with a navigationbracket, drive enclosure, and wire sorter attached thereto;

FIG. 52 is a cross-sectional view taken along the line 52-52 in FIG. 51;

FIG. 53 is an exploded view of the wire sorter;

FIG. 53A is a perspective view of a ferrule;

FIG. 54 is an exploded view of the contents of the shell in which themotor controllers are housed;

FIG. 55 is an exploded view of the navigation bracket;

FIG. 56 is a top and front perspective view of the instrumentillustrating the range of motion of the end effector;

FIG. 57 is a cross-sectional view of the end effector;

FIG. 58 is a flow chart showing the initialization steps of the system;

FIG. 59 is a flow chart showing the operational steps taken during useof the system;

FIG. 60 is a perspective view of a surface model of a work boundary;

FIG. 61 is a perspective view of a volume model of a work boundary;

FIG. 62 is an illustration showing a bur head outside of the workboundary;

FIG. 63 is an illustration showing the bur head at the work boundary;

FIG. 64 is a chart of a speed profile of the bur with respect to burdeflection;

FIG. 65 is an illustration of an application of the invention for use inbone sculpting;

FIG. 66 is an illustration of an application of the invention for use inbore tunneling;

FIGS. 67A-67C are illustrations of an application of the invention foruse in targeting/alignment;

FIG. 68 is an illustration of a potential display located on theinstrument;

FIG. 69 is an illustration of an application of the invention for use inavoiding tissues or nerves;

FIG. 70 is an illustration of an application of the invention for use indepth control;

FIG. 71 is an illustration of an application of the invention for use inshaping implants;

FIG. 72 is a perspective view of a pencil-grip embodiment of theinstrument including a proximal assembly and a distal assembly;

FIG. 73 is another perspective view of the instrument of FIG. 72;

FIG. 74 is an exploded view of a portion of the instrument of FIG. 72;

FIGS. 75A-C are cross-sectional views of the instrument of FIG. 72 invarious pitch positions;

FIG. 76 is a cross-sectional view of a portion of the instrument of FIG.72;

FIG. 77 is a cross-sectional view of another portion of the instrumentof FIG. 72;

FIG. 78 is a perspective view of a distal portion of the instrument ofFIG. 72;

FIG. 79 is an exploded view of the distal portion;

FIG. 80 is a perspective view of a nose tube;

FIG. 81 is a cross-sectional view of a collet assembly;

FIG. 82 is another cross-sectional view of the collet assembly;

FIG. 83 is an exploded view of the collet assembly;

FIG. 84 is a partially exploded view of a shaft between a collar and thecollet assembly;

FIGS. 85-87 are cross-sectional views of the instrument in variouspositions along a z-axis;

FIG. 88 is a cross-sectional view of a portion of the instrument withthe shaft positioned such that the cutting accessory can be removed uponfurther retraction of the nose tube;

FIG. 89 is a cross-sectional view of a portion of the instrument withthe collet assembly in an unlocked position;

FIG. 90 is a cross-sectional view of the nose tube;

FIG. 91 is a perspective view of the lead screw

FIG. 92 is a cross-sectional view of the lead screw;

FIG. 93 is a cross-sectional view of an embodiment of the nose tubeincluding an anti-backlash device;

FIG. 94 is another cross-sectional view of the anti-backlash device;

FIG. 95 is a cross-sectional view of a portion of the instrument of FIG.72 including a gimbal;

FIG. 96 is a cross-sectional view of an adjustment assembly;

FIG. 97 is a perspective view of the adjustment assembly;

FIG. 98 is another perspective view of the adjustment assembly;

FIG. 99 is a cross-sectional view of the adjustment assembly;

FIG. 100 is another cross-sectional view of the adjustment assembly;

FIG. 101 is a perspective view of a portion of the adjustment assembly;

FIG. 102 is a perspective view of a carriage and a connecting member ofthe adjustment assembly;

FIG. 103 is a cross-sectional view of the carriage;

FIG. 104 is a perspective view of the connecting member;

FIG. 105 is another embodiment of the adjustment assembly including ananti-backlash device;

FIG. 106 is a perspective view of a portion of the adjustment assemblyof FIG. 105;

FIG. 107 is a view of a display screen including a target reticle, adepth legend, an extension extending from the depth legend, anacceptance circle, and an orientation legend;

FIG. 108 is a view of a display screen including a target reticle, adepth legend, an extension extending from the depth legend, anacceptance circle, an orientation legend, and a translation legend;

FIG. 109 is a view of a display screen including a target reticle, adepth legend, an extension extending from the depth legend, and anorientation legend;

FIG. 110 is a view of a display screen including a target reticle, adepth legend, an acceptance bar, and a translation legend;

FIG. 111 is a view of the display screen including a target reticle, adepth legend, and a translation legend;

FIGS. 112A through 112D illustrate steps of performing a surgicalfusion;

FIGS. 113A and 113B illustrate steps of alleviating impingement betweena femoral head and an acetabulum;

FIG. 114 illustrates an anterior cruciate ligament repair using a graftplaced through passages formed in the femur and tibia;

FIGS. 115A and 115B illustrate steps of repairing a focal cartilagedefect; and

FIG. 116 illustrates formation of a pocket in bone to receive a cranialimplant.

DETAILED DESCRIPTION

I. Overview

Referring to FIG. 1, a tracking and control system 100 is shown.Tracking and control system 100 tracks instrument 200 to keep a distalend tip 204 of a cutting accessory 202 that is attached to instrument200 in a desired relationship to a predefined boundary. (Here “distal”means away from the practitioner holding the instrument 200 and towardsthe tissue to which the instrument is applied. “Proximal” means towardsthe practitioner and away from the tissue to which the instrument isapplied.) The tracking and control system 100 controls the position ofthe cutting accessory tip 204 relative to a reference point on theinstrument 200. This control prevents the cutting accessory tip 204 fromcolliding with or breaching a boundary at the surgical site to which thecutting accessory 202 is applied.

Tracking and control system 100 can be used to keep the accessory distalend tip 204 outside of a predefined boundary. For example, it may bedesirable to keep an active tip of an ablation instrument away fromcertain regions inside the body or away from certain body parts. It mayalso be desirable to control a depth of cutting. In this respect, thesystem 100 controls the position of the accessory distal end tip 204 toavoid those regions or body parts.

The depicted surgical instrument 200 is a motorized surgical handpiece.The instrument 200 includes a drive mechanism 201, for example,referenced in FIGS. 8, 16, and 57, coupled to a working portion, e.g.,cutting accessory 202. In some embodiments where the cutting accessory202 rotates, e.g., a bur, a drill bit, etc., the drive mechanism 201rotates the working portion about a rotational axis R. As set forthfurther below, with respect to the instrument 200, the rotational axis Rmoves relative to a hand-held portion, e.g., handle assembly 500, inpitch, yaw, and along an axis Z. The drive mechanism 201 includes amotor 206 and can include other bearings, rods, etc., to transferrotation from the motor 206 to the working portion, i.e., cuttingaccessory 202.

A coupling assembly 207, seen in cross section in FIG. 16, is locatedforward of motor 206. Coupling assembly 207 releasably holds differentcutting accessories 202 to the instrument 200. The coupling assembly 207also provides a mechanical linkage between the motor 206 and accessory202 so the accessory 202 can be actuated by the motor 206. The cuttingaccessory 202 is the component that performs a medical/surgical task onthe tissue of a patient. The types of cutting accessories that can bedriven by instrument 200 include, saw blades, shavers, drill bits andburs. In FIG. 1, the depicted cutting accessory 202 is a bur that has atits distal end a spherical bur head 204 for removing bone.

With reference to FIGS. 16 and 17, a sleeve 209, also referred to as anose tube, at least partially covers the cutting accessory 202. Cuttingaccessory 202 moves with sleeve 209 as the cutting accessory 202 movesabout a plurality of degrees of freedom, e.g., pitch, yaw, andtranslation along axis Z, as discussed further below. The axis Z is alsoreferred to as a z-axis. The sleeve 209 remains stationary aboutrotational axis R, i.e., the cutting accessory 202 is configured torotate within the sleeve 209 during the medical procedure.

Tracking and control system 100 can track and control other types ofsurgical instruments 200. These instruments include powered surgicalinstruments that output energy other than mechanical energy such as:electrical energy; photonic energy (light); RF energy; thermal energy;and that vibrate (emit mechanical energy in the form of vibrations). Asurgical instrument 200 of this invention may not even have a poweremitting component. The instrument 200 may include a cutting accessory202. Alternatively, the cutting accessory 202 may be manually actuated.Examples of manually actuated cutting accessories include forceps andsnares.

The illustrated instrument in FIGS. 1 and 1A with bur as the cuttingaccessory 202 is shown being used to shape a portion of a femur 102. Theinstrument 200 can be used to remove other types of tissue, includingsoft tissue.

With continued reference to FIG. 1, the embodiment shown, the femur 102has a target volume 104 of material that is to be removed by the burhead 204. The target volume 104 is defined by a boundary 106 called thework boundary. This work boundary 106 defines the surface of the bonethat should remain after the procedure. System 100 tracks and controlsinstrument 200 to ensure that bur head 204 only removes the targetvolume 104 of material and does not extend beyond the work boundary 106.It should be appreciated that the work boundary in other embodiments maybe defined by any shape or size and may include 2-D or 3-D shapes,lines, trajectories, surfaces, linear paths, non-linear paths, volumes,planes, bore holes, contours, and the like. In some embodiments, thework boundary can define a 2-D or 3-D boundary across which theinstrument should not cross. In other embodiments, the work boundary maydefine a line, path, trajectory or course along which the workingportion of the instrument should travel. In these cases, the workboundary is also referred to as a work path, work trajectory or workcourse.

II. Tracking and Control System

Referring to FIG. 1, the tracking and control system 100 includes anavigation unit 108. The navigation unit 108 tracks the positions andorientations of the femur 102 and surgical instrument 200. Thenavigation unit 108 includes a camera 110. A navigation computer 112receives and processes signals from the camera 110. The camera 110 isconnected to the navigation computer 112 by data connection 107. Dataconnection 107 may be an IEEE 1394 interface, which is a serial businterface standard for high-speed communications and isochronousreal-time data transfer. Data connection 107 could also use a companyspecific protocol.

One camera 110 that can be incorporated into system 100 is theFlashPoint® 6000 Camera sold by Stryker Corporation of Kalamazoo, Mich.The camera 110 includes three separate high resolution CCD cameras (notshown). The CCD cameras detect infrared (IR) signals. Camera 110 ismounted to a stand (not shown) to position the camera 110 above the zonein which the procedure is to take place to provide the camera 110 with afield of view of the below discussed trackers 114 and 116 that, ideally,is free from obstructions. Trackers 114 and 116 are also referred to astracking devices 114 and 116, respectively.

The navigation computer 112 can be a personal computer such as a laptopcomputer. Navigation computer 112 has a display 113, central processingunit (not shown), memory (not shown), and storage (not shown).

The navigation computer 112 is loaded with software. The softwareconverts the signals received from the camera 110 into datarepresentative of the position and orientation of the objects to whichtrackers 114 and 116 are attached. Also associated with the navigationcomputer 112 is a mouse or other suitable pointer-input device andkeyboard.

The camera 110 communicates with the navigation computer 112 via dataconnection 107. The navigation computer 112 initially sets up andregisters the navigation unit 108. The software provides a graphicaluser interface (GUI). The software also provides the geometry andpositioning of the work boundary 106. The navigation computer 112interprets the data received from the camera 110 and generatescorresponding position and orientation data that is transmitted to aninstrument controller 120.

With reference to FIG. 1, for example, trackers 114 and 116 are affixedto the instrument 200 and the femur 102, respectively. Specifically, thetracker 114, i.e., the tracking device 114, is attached to a hand-heldportion of the instrument 200, as discussed below, for tracking theinstrument 200. Each tracker 114 and 116 has a plurality of opticalmarkers in the form of light emitting diodes, such as three LEDs (notshown), that transmit infrared light to the camera 110. In some cases,the optical markers are three or more light reflectors (not shown) foruse with a camera unit (not shown) that transmits light that reflectsoff the light reflectors. In other procedures, additional trackers maybe affixed to other bones, tissue, or other parts of the body, tools, orequipment.

Based on the light captured signals forwarded from the camera 110, thenavigation computer 112 determines the position of each optical markerand thus the position and orientation of the objects to which they areattached relative to the camera 110. An example of the camera 110,navigation computer 112, and trackers 114, 116 are shown in U.S. Pat.No. 7,725,162 to Malackowski et al., hereby incorporated by reference,including the camera, navigation computer and trackers and associatedmethods of operation and use disclosed therein.

The instrument controller 120 is in communication with the navigationcomputer 112 via a data connection 121. Data connection 121 may be anIEEE 1394 interface, which is a serial bus interface standard forhigh-speed communications and isochronous real-time data transfer. Dataconnection 121 could use a company specific protocol. It should beappreciated that in some versions of this invention navigation computer112 and instrument controller 120 may be single unit. Instrumentcontroller 120 communicates with the instrument 200 by a data connection123.

Based on the position and orientation data and other below describeddata, the instrument controller 120 determines the position andorientation of the cutting accessory 202 relative to the femur 102. Byextension, the instrument controller 120, determines the relativelocation of the accessory tip such as the bur head 204 to the workingboundary 106. Based on this determination, the controller 120, ifnecessary, repositions the cutting accessory and attenuates the speed ofthe instrument motor 206 as discussed further below. Instrumentcontroller 120 typically performs these operations in a single controlloop. In many versions of the invention, the controller 120 repeatedlyexecutes these control loops at a frequency of at least 1 kHz. In someversions of the invention, controller 120 includes plural CPUs.Depending on the structure of the controller 120 these CPU's operate inseries and/or parallel. In FIG. 1, instrument controller 120 isrepresented as a personal computer.

System 100 further includes an instrument driver 130. Instrument driver130 provides power to instrument motor 206 to control the motor 206. Thepower supply and control components internal to driver 130 may besimilar those in the surgical instrument control console described inU.S. Pat. No. 7,422,582, CONTROL CONSOLE TO WHICH POWERED SURGICALHANDPIECES ARE CONNECTED, THE CONSOLE CONFIGURED TO SIMULTANEOUSLYENERGIZE MORE THAN ONE AND LESS THAT ALL OF THE HANDPIECES herebyincorporated by reference, including the power supply and controlcomponents of the control console disclosed therein and associatedmethods of operation and use. Instrument driver 130 is in communicationwith the instrument controller 120 via a data connection 131. Dataconnection 131 may be an IEEE 1394 interface, which is a serial businterface standard for high-speed communications and isochronousreal-time data transfer. Data connection 131 could use a companyspecific protocol. It should be appreciated that in other embodimentsthe instrument driver 130 could be integrated into or part of theinstrument controller 120.

With reference to FIGS. 1-8, for example, a manually actuated trigger208 mounted to the instrument 200 is selectively depressed to regulateactuation of the instrument motor 206. A sensor (not identified)disposed inside the instrument 200 generates a signal as a function ofthe extent to which the trigger 208 is actuated. The output signals fromthe sensor are forwarded by a data connection 133 to the instrumentdriver 130. Based on the state of this sensor signal and other inputsdescribed below, the instrument driver 130 applies energization signalsto the instrument motor 206.

Display 113 shows a virtual representation (or 3-D model) of the femur102 and cutting accessory 202. The representation of the femur 102 isbased on preoperative images taken of the femur 102. Such images aretypically based on MRI or CT scans. Alternatively intraoperative imagesusing a fluoroscope, low level x-ray or any similar device could also beused. These images are registered to the tracking device 116 fortracking purposes. Once registered, movement of the femur 102 results incorresponding movement of the images on the display 113. This can alsobe displayed on the display 1402 (see below). Screen shots of display1402 are shown in FIG. 68 and in FIGS. 107-111. It should be appreciatedthat the various features shown on the screen shots in FIGS. 68 and107-111 can be used in any combination.

The instrument 200 and the femur 102 are registered to the navigationunit 108 to ensure that the position and orientation data corresponds totheir true relative positions within an acceptable level of accuracy.

The display 113 (and/or 1402) also shows the work boundary 106 usingcolor coding, or other visual method of distinguishing the target volume104 of material to be removed from material that is to remain in thefemur 102.

Referring to FIG. 1A, the instrument controller 120 defines a constraintboundary 111 that is located a predetermined distance from the workboundary 106 to define a buffer 105. In one implementation of thesystem, the instrument controller 120 determines the position of thecenter of the bur head 204, relative to the constraint boundary 111 tocontrol the instrument 200. The relative distance between the workingboundary 106 and the constraint boundary 111 is a function, in part, ofthe geometry of the cutting accessory 202. For example, if the cuttingaccessory 202 includes a spherical bur head 204, the constraint boundaryis one-half the diameter of the bur head 204. Thus, when the centroid ofthe bur head 204 is on the constraint boundary 111, the bur's outercutting surface is at the work boundary 106.

III. Surgical Instrument

A. Overview

Referring to FIG. 1, surgical instrument 200 communicates with theinstrument controller 120 via the data connection 123. The dataconnection 123 provides the path for the input and output required tocontrol the instrument 200 based on the position and orientation datagenerated by the navigation computer 112 and transmitted to theinstrument controller 120.

The instrument 200 includes a hand-held portion, e.g., a handle assembly500 as discussed further below, and a working portion, e.g., the cuttingaccessory 202. The working portion is movably coupled to the hand-heldportion. The hand-held portion is manually supported and moved by a userduring the medical procedure to treat the tissue of a patient with theworking portion. The user operates the instrument 200 by grasping andsupporting hand-held portion, and the instrument 200 is unsupported byother mechanical arms, frames, etc.

The instrument 200 has a plurality of actuators, e.g., motors 220, 222and 224. The motors 220, 222, and 224 are coupled to the workingportion, e.g., the cutting accessory 202, for moving the working portionin a plurality of degrees of freedom relative to the hand-held portion,e.g., the handle assembly 500. Each motor 220, 222 and, 224 iscontrolled by a separate controller 230, 232, 234, respectively.Controllers 230-234 can be those provided by Technosoft U.S., Inc. ofCanton, Mich., part number IBL2401-CAN. In some embodiments, the motors220, 222, 224 can be controlled by a single controller. Controllers 230,232 and 234 are wired separately to the motors 220, 222 and 224,respectively to individually direct each motor to a given targetposition. In some versions of the invention, controllers 230, 232 and234 are proportional integral derivative controllers. The dataconnection 123 may be a CAN-bus interface between the instrumentcontroller 120 and the controllers 230, 232, 234 or any other high speedinterface. In other embodiments, the controllers 230, 232, 234 can beintegrated with or form part of the instrument controller 120.

A power source 140 provides, for example, 24 VDC power signals to themotors 220, 222 and 224. The 24 VDC signal is applied to the motors 220,222, and 224 through the controllers 230, 232 and 234. Each controller230, 232 and 234 selectively provides the power signal to thecomplementary motor 220, 222 and 224, respectively, to selectivelyactivate the motor. This selective activation of the motors 220, 222 and224 is what positions the cutting accessory 202. Power source 140 alsosupplies power to the controllers 230, 232 and 234 to energize thecomponents internal to the controllers. It should be appreciated thatthe power source 140 can provide other types of power signals such as,for example, 12 VDC, 40 VDC, etc.

The motors 220, 222, 224 move the cutting accessory 202 and, byextension the bur head 204, when the bur head 204 approaches, meets, orexceeds the constraint boundary 111. For example, the instrumentcontroller 120 may determine that the bur head 204 is crossing theconstraint boundary 111 as the bur head 204 removes bone. In response,the instrument controller 120 transmits a signal to at least one of thecontrollers 230, 232 or 234 that causes the deflection of the cuttingaccessory 202 that moves the bur head 204 away from the constraintboundary 111.

In one version of the invention, motors 220, 222 and 224 are brushlessDC servomotors. One servomotor is available from MICROMO of Clearwater,Fla., Part No. 1628T024B K1155. Each servomotor includes threeintegrated linear Hall-effect sensors (not shown) that transmit signalsback to the instrument controller 120. The levels of these signals varyas a function of the rotational position of the associated motor rotor.These Hall-effect sensors output analog signals based on the sensedmagnet fields from the rotor. In the above-described motor, the sensorsare spaced 120° apart from each other around the rotor. A low voltagesignal, typically, 5 VDC, for energizing the motor Hall effect sensorsis supplied from the controller 230, 232 or 234 associated with themotor 220, 222 or 224 in which the Hall-effect sensors are located.

The output signals from the Hall-effect sensors internal to each motor220, 222 and 224 are applied to the associated controller 230, 232 and234, respectively. Each controller 230, 232 and 234, monitors thereceived signals for changes in their levels. Based on these signals thecontroller 230, 232 or 234 determines the rotor position. Here “rotorposition” is understood to be the degrees of rotation of the rotor froman initial or home position. A motor rotor can undergo plural 360°rotations. A rotor position can therefore exceed 360°. Each motorcontroller 230, 232 and 234 maintains a scalar value referred to as a“count” representative of rotor position from the home position. Themotor rotors rotate in both clockwise and counterclockwise directions.Each time the signal levels of the plural analog signals undergo adefined state change, the controller 230, 232 and 234 increments ordecrements the count to indicate an arcuate change in rotor position.For every complete 360° rotation of the motor rotor, the associatedmotor controller 230, 232 and 234 increments or decrements the value ofthe count by a fixed number of counts. In some versions of theinvention, the count is incremented or decremented between 1500 and 2500per 360° revolution of the rotor.

Internal to each controller 230, 232 and 234 is a counter (notillustrated). The counter stores a value equal to the cumulative numberof counts incremented or decremented by the controller 230, 232 or 234.The count value can be positive, zero or negative.

Referring to FIGS. 2 through 8, various views of the surgical instrument200 are shown. This includes views of the instrument 200 with protectivecovers 240 a, 240 b (FIGS. 2-5) and without protective covers 240 a, 240b (FIGS. 6-8). The protective covers 240 a, 240 b are two halves of ahousing for an upper assembly 300 of the instrument 200. The upperassembly 300 includes a drive assembly 314 that drives the cuttingaccessory 202. Covers 240 a, 240 b are placed on either side of theupper assembly 300 and fastened together by fasteners or the like. Inother embodiments, the protective covers 240 a, 240 b may be replaced bya one-piece covering or housing (not shown).

In addition to the upper assembly 300, the instrument 200 includes thehandle assembly 500, a shell 670, and a bracket assembly 700. The driveassembly 314 is coupled to the hand-held portion, e.g., handle assembly500. The drive assembly 314 is slidably coupled to the handle assembly500. Bracket assembly 700 and shell 670 are fixed to the handle assembly500. Cutting accessory 202 extends distally forward from upper assembly300. The handle assembly 500 includes a pistol-grip style handle 502 forbeing manually handled by a user and the trigger 208. Other embodimentshave alternative handles with differing grip styles, such as a pencilgrip.

B. Upper Assembly

Referring to FIGS. 9-17, 24 and 41, various views of the upper assembly300, of the instrument 200 are shown. The upper assembly 300, and morespecifically the drive assembly 314, supports the working portion, e.g.,the cutting accessory 202. As set forth further below, the upperassembly 300 and the cutting accessory 202 move relative to thehand-held portion, e.g., the handle assembly 500, in a plurality ofdegrees of freedom.

The drive mechanism 201 moves in at least one degree of freedom relativeto the hand-held portion, e.g., handle assembly 500. Specifically, thedrive motor 206 moves in at least two degrees of freedom relative to thehand-held portion and, more specifically, moves in at least threedegrees of freedom relative to the hand-held portion. At least one ofthe actuators moves the drive mechanism 201 and the drive motor 206 inpitch, yaw, and translation along the axis Z relative to the hand-heldportion. Specifically, the motors 220, 222, and 224 move the drivemechanism 201 and the drive motor 206 in pitch, yaw, and translationalong the axis Z, respectively, relative to the hand-held portion.

As best shown in FIGS. 18-27 and 56, the plurality of actuators, e.g.,motors 220, 222, and 224, are capable of moving the working portionrelative to the hand-held portion in at least three degrees of freedomincluding pitch, yaw, and translation along the axis Z. These individualdegrees of freedom are best shown in FIGS. 18-20 (pitch), FIGS. 21-23(yaw), and FIGS. 37-39 (z-axis). FIGS. 24-27 show a sample of possiblepositions for pitch and yaw, and FIG. 56 shows the resulting range ofmotion when all three degrees of freedom are expressed. Further, in anembodiment where the working portion, i.e., the cutting accessory 202,comprises a bur head 204, the drive motor 206 moves in four degrees offreedom relative to the hand-held portion, i.e., the drive motor 206rotates the bur head 204.

The upper assembly 300 includes a carrier 302, as identified in FIG. 17,for example. Carrier 302 is slidably mounted to handle assembly 500. Thecarrier 302 is in the form of a single piece metal structure that isoften formed from aluminum. Carrier 302 is shaped to have a base 305that is in the form of a rectangular frame. A riser 307, also part ofthe carrier 302, extends vertically upwardly from the proximal end ofthe base. Flanges 303 extend outwardly along the opposed outer sideedges of the base 305. The flanges 303 ride in channels 504 formed inhandle assembly 500. As seen in FIG. 43, the carrier 302 is furtherformed to have an elongated slot 317 that extends upwardly from thedownwardly directed face of carriage base 305. Slot 317 is semi-circularin cross sectional shape and extends the length of the base 305. Slot317 is centered on the longitudinal axis that extends along thedownwardly directed face of the slot base 305.

With reference to FIG. 17 a gimbal housing 306 is mounted to carrierbase 305. Gimbal housing 306 holds a gimbal 304 disposed around motor206 to pivotally secure the motor 206 to the carrier 302. Workingportion, e.g., cutting accessory 202, moves about gimbal 304 in at leasttwo degrees of freedom relative to the hand-held portion, e.g., handleassembly 500. Specifically, the working portion is adjustable in pitchand yaw about the gimbal 304. The gimbal 304 is movable along the axis Zrelative to the hand-held portion, e.g., handle assembly 500.

Gimbal 304 is a ring shaped structure that has an outer shape of spherethe opposed ends of which have been removed. Gimbal 304 holds thecutting accessory 202 to the upper assembly 300 so the cutting accessory202 is able to pivot around two axes. More particularly, motor 206 andcoupling assembly 207 are the components of the instrument 200 securelyattached to the gimbal 304. Gimbal 304 is located around the center ofgravity of a subassembly consisting of the cutting accessory 202, motor206 and coupling assembly 207. This minimizes the mass moment of inertiaof the sub assembly as it is pivoted and maximizes the angularacceleration for a given supplied torque.

With continued reference to FIG. 17, the gimbal housing 306 includes anupper collar 308 and a lower collar 310. Collars 308 and 310 are bothgenerally U-shaped. Upper collar 308 is mounted to a lower collar 310 byfasteners 301. Fasteners 309 mount the lower collar 310 to the carrierbase 305. The opposed inner faces of collars 308 and 310 have surfacesthat conform to slice sections through a sphere. Gimbal 304 issandwiched between the collars 308 and 310. Gimbal housing 306 andgimbal 304 are collectively shaped to both prohibit lateral andlongitudinal movement of the gimbal yet allow the pivoting of the motor206 and cutting accessory 202 in two degrees of freedom relative to thelongitudinal axis extending through the gimbal housing 306.

A fastener 424 prevents rotation of the gimbal 304 relative to thegimbal housing 306 in the roll direction, around the longitudinal axisthrough the housing 306. Fastener 424 has a distal protrusion, that wheninstalled in the upper collar 308, mates in a slot 425 in the gimbal304. The slot 425 extends longitudinally along the gimbal 304. Theseating of stem of the fastener 424 in slot 425 inhibits rotation of thegimbal 304 and, by extension the cutting accessory 202 while allowingpitch and yaw adjustment of the cutting accessory 202.

With continued reference to FIG. 17, upper assembly 300 includes a pitchadjustment mechanism 312 that sets the pitch of the cutting accessory202. Here the “pitch” is the up-down angular orientation of alongitudinal axis or rotational axis R of the cutting accessory 202relative to a horizontal plane through the center of the gimbal housing306. A yaw adjustment mechanism 412 sets the yaw of the cuttingaccessory 202. “Yaw” is the right-left angular orientation of thelongitudinal or rotational axis of the cutting accessory 202 relative toa vertical plane through the center of the gimbal housing 306. Pitch andyaw adjustment mechanisms 312 and 412, respectively, are actuated tosimultaneously adjust the pitch and yaw of the cutting accessory 202.The pitch adjustment mechanism 312 and the yaw adjustment mechanism 412are also capable of independent adjustment.

The pitch adjustment mechanism 312 includes a link 316, sometimes calleda swing arm, that is a three-sided structure. Link 316 includes a base319 from which a pair of parallel arms 318 extends distally outwardly.Link 316 is positioned so that the base 319 is located proximal to thecarrier riser 307 and the free ends of the arms 318 are disposed againstopposed sides of the lower collar 310. The outer end of each arm 318 hasa bore 320 with a counterbore 321. A flanged bearing 322 is seated ineach bore 320 and counterbore 321. A screw 324 extends through eachbearing 322. The screw 324 has a head 326 that holds the flanged bearing322 to the arm 318. Each screw 324 also has a threaded shaft 328 thatengages a corresponding threaded bore 330 formed in the adjacent side ofthe lower collar 310. Link 316 pivots relative to the gimbal housing 306about the axis through the coaxial screws 324. This axis extends throughthe center of the gimbal 304.

Link base 319 is formed to have an elongated slot 332. Slot 332 receivesa guide post 334 extending from a proximal end of motor 206. The guidepost 334 rides in the slot 332 when the yaw of the cutting accessory 202is being adjusted. When the pitch is being adjusted, the guide post 334is moved by the link 316 to place the bur head 204 in the desired pitchposition. The slot 332 is dimensioned with a relatively tight toleranceto the guide post 334 across its width, while still allowing the guidepost 334 to freely slide in the slot 332 as the yaw of the cuttingaccessory 202 is changed. In one version of the invention guide post 334has a diameter of 0.4 cm and, the width across the slot 334 isapproximately 0.01 to 0.05 mm wider. The length across the slot 334 isapproximately 2.1 cm.

Pitch adjustment mechanism 312 includes a lead screw 336 that is drivenby motor 220. The lead screw 336 has opposed first and second stems, 338and 340, respectively, that are cylindrical in shape. Stems 338 and 340are located on opposing sides of a screw body 339 formed with threading(threading not illustrated). Each screw stem 338 and 340 is seated in aseparate bearing 342. Bearing 342 are located in opposed coaxial bores344, 345 formed in the carrier 302. One bore, bore 344, is formed in aportion of the riser 307. The second bore, bore 345, is formed in thecarrier base 305. An end plug 346 is threaded into a matching internalthread 347 formed in the riser 307 around bore 344 to secure thebearings 342 and lead screw 336 to the carrier 302.

A spur gear 348 is fit over the upper of the two screw stems, stem 338.Set screws, (not identified) hold the spur gear 348 to the stem 338 sothat the gear rotates in unison with the stem 338. Spur gear 348 hasteeth that mate with teeth on a spur gear 352. Spur gear 352 is fixed tothe output shaft 354 of the pitch motor 220 by set screws (notidentified). FIG. 17A shows a cross-section through the lead screw 336.A mounting bracket 358 secures the motor 220 to the proximally directedface the of carrier riser 307 with fasteners 360. Specifically, thecarrier riser 307 is formed to have an arcuate recess 362 that extendsinwardly from the proximally directed face of the riser 307. Recess 362is shaped to receive a section of the cylindrically shaped motor 220.Mounting bracket 358 is arcuate in shape so as to seat around theportion of the motor 220 that extends outward of the carrier riser 307.

Pitch adjustment mechanism 312 further includes a yoke assembly 364. Theyoke assembly 364 includes a rectangular bar 366. Bar 366 is formed soas to have an elongated bore 372, only the openings of which are seen,that extends longitudinally through the bar 366. Threaded fasteners 374secure bar 366 to the outer face of the arm 318 of link 316 adjacentlead screw 336. While not illustrated, bar 366 may be formed with a ribthat projects outwardly from the face of the bar 366 that is disposedagainst the adjacent arm 318. The rib has a width thereacross less thanthe width of the bar 366. The link arm 318 is formed with a groovehaving a width that allows the close seating of the rib. Thisrib-in-groove facilitates the securing of the bar 366 to the link. Thisrib also allows bore 372 to be positioned relatively close to the linkarm 318.

Yoke assembly 364 further includes a three sided yoke 368. A rod 370 isintegral with the yoke 368 and extends distally forward from the yoke368. The rod 370 is cylindrical in shape. The rod 370 is slidablydisposed in the bore 372 internal to bar 366. A nut 376 is pivotallymounted to the yoke 368. Nut 376 is formed to have opposed trunnions377. Each trunnion 377 seats in a bearing assembly 379 mounted to a sidesection of the yoke 368 (see FIG. 17A). The nut 376 has internal threadsthat mate with the lead screw 336.

The cutting accessory 202 is pivoted up and down, along the Y-axis, byactuating motor 220. The resultant rotation of motor output shaft 354 istransferred through gears 352 and 348 to cause a like rotation of leadscrew 336. Nut 376 is attached to yoke 368. Yoke 368 is, through rod 370attached to link 316. As a consequence of the attachment of nut 376 tothe link 316, the nut 376 is blocked from rotation. Consequently, therotation of lead screw 336 results in the movement of the nut 376 up ordown the lead screw 336. The displacement of the nut 376 results in adisplacement of rod 370 that results in a like displacement of the link316. During this displacement, the yoke 368 pivots around nut trunnions377. Rod 370 freely slides in and out of bore 372 internal to plate 366.As a consequence of the up/down displacement of the portion of thebracket adjacent shaft, link 316 pivots about the axis through bearings322. When the pitch adjuster 316 pivots, the guide post 334 is forced toundergo a like displacement. This displacement of the guide post forcesthe motor 206 and cutting accessory 202 to likewise pivot. It should beunderstood that the downward pivoting of link 316 and guide post 334cause an upward pivoting of the bur head 204.

Lead screw body 339 has fine pitch and lead angle to prevent backdriving(i.e. it is self-locking). As a result, a load placed on the bur head204 does not back drive the motor 220. In one embodiment, the lead screwbody 339 has a diameter of 0.125 inches (0.318 cm) and has a lead of0.024 inches/revolution (0.061 cm/revolution). One such lead screw isavailable from Haydon Kerk Motion Solutions, Inc. of Waterbury, Conn.

Magnets 380 are mounted in a pair of pockets (not identified) defined inan outside surface of one of the link arms 318. A plate 384 is mountedto the arm 318 by fasteners (not identified) to hold the magnets 380 inthe pockets. Magnets 380 are mounted to the arm 318 so that the Northpole of the first magnet and the South pole of the second magnet areadjacent the plate 384. The magnets 380 are used to establish the zeroed(or “home”) position for the cutting accessory 202 on the X-axis.

Yaw adjustment mechanism 412 includes a link 416 similar in shape tolink 316. While not apparent from FIG. 17, as seen in FIGS. 11 and 12,link 416 is located distally forward of link 316. Link 416 includes abase 419 from which a pair of parallel arms 418 extends distallyforward. A first end of each arm 418 has a bore 420 with a counterbore421. A flanged bearing 422 is supported in each bore 420 and counterbore421. Fastener 424, the fastener that seats in the flanged bearing 422,has a head 426 that holds the flanged bearing 422 to the top located arm418. Fastener 424 also has a threaded shaft 428 that engages acorresponding threaded bore 430 formed in upper collar 308. A fastener425, similar but not identical to fastener 424, holds the bottom locatedarm against lower collar 310. Fastener 425 extends into a bore formed inthe lower collar 310 (bore not identified). Link 416 is able to freelypivot relative to the carrier 302 about an axis defined by the flangedbearings 422. This axis extends through the center of the gimbal 304.

An elongated slot 432 is formed in link base 419. Slot 432 is centeredon and extends along the longitudinal axis of link base 419. Slot 432,like the slot 332 integral with link 316, receives the guide post 334extending from the proximal end of motor 206. Slot 432 has a length ofapproximately 2.0 cm. Slot 432 is slightly smaller in end-to-end lengththan slot 332 integral with link 316 because the pitch of link 416 isgreater than the yaw of link 316. Consequently to ensure the sameup/down and right/left arc of the distal end of the cutting accessory202, the movement of post 334 to the left and right of link 416 shouldbe less than the movement of the post 334 up and down relative to link316. The side-to-side width across slot 432 is approximately equal tothe side-to-side width across slot 332. Guide post 334 freely moves upand down in the slot 432 when the pitch of the cutting accessory 202 isadjusted. When cutting accessory 202 yaw is adjusted, the guide post 334is moved by the yaw adjustment mechanism 412 to place the bur head 204in the desired position. The slot 432 is dimensioned with a relativelytight tolerance to the guide post 334 across its width, while stillallowing the guide post 334 to freely slide in the slot 432 as the pitchof the cutting accessory 202 is changed by the instrument controller120.

The yaw adjustment mechanism 412 includes a lead screw 436 that isrotated by the motor 222. The lead screw 436 has opposing first andsecond stems, 438 and 440, respectively. Stems 438 and 440 arecylindrical in shape. The lead screw 436 has a threaded portion 439located between stems 438 and 440. The stems 438 and 440 are rotatablysupported by two bearings 442 (with bushings (not numbered) in between).The bearings 442 are located in opposing bores 444, 445 formed in thecarrier 302. An end plug 446 is threaded into a matching internal thread447 in the carrier 302 to secure the bearings 442 and lead screw 436 tothe carrier 302. The first stem 438 supports a spur gear 448 that isfixed to the screw 436 by set screws (not identified). The spur gear 448has teeth that mate with teeth on a spur gear 452. The spur gear 452 isfixed to an output shaft 454 of yaw motor 222 by set screws (notidentified). FIG. 17B shows a cross-section through lead screw 436.

A mounting bracket 458 secures motor 222 to the carrier 302 withfasteners (not identified). In particular, the proximal end of thecarrier base 305 is formed with an arcuate recess 462 for receiving asection of the cylindrically shaped motor 222. Mounting bracket 458 hasan arcuate shape to seat over the portion of the motor that extendsbeyond the carrier 302 to hold the motor 222 in position.

The yaw adjustment mechanism 412 further includes a yoke assembly 464mounted to link 416. Yoke assembly 464 includes a rectangularly shapedbar 466. Bar 466 is formed to have a bore 472, only the opening of whichis seen, that extends longitudinally through the bar 466. Bar 466 issecured to the outer face of the bottom of two arms 418 of link 416 byfasteners (not identified). The bar 466 is secured to the adjacent arm418 so that the bore 472 is directed towards the arm 418. Bar 466 may beidentical to bar 366. Accordingly, the adjacent link arm 418 may have arecess for receiving a rib integral with the bar 466.

The yoke assembly 464 includes a three sided yoke 468. A cylindrical rod470, integral with the yoke 468 extends distally forward of the yoke468. The rod 470 is slidably disposed in bore 472 between bar 466 andthe adjacent link arm 418.

A nut 476, identical to nut 376, is pivotally mounted to the yoke 468 bytrunnions 477. Each trunnion 477 is seated in a bearing assembly mountedto the side of yoke 468. The nut 476 has internal threads that mate withthreads on the lead screw 436. The connection of nut 476 to link 416 byyoke 468 and rod 470 prevents the nut 476 from rotation. Consequently,the rotation of lead screw 436 results in the right/left movement of thenut 476 along the screw 436. Yoke 468 and, by extension, rod 470, moveto the right/left with the movement of nut 476. The rod 470, beingslidably coupled to the link 416 and bar 466, causes the link 416 toengage in the like displacement. During the movement of these componentsit should be appreciated that the yoke 468 pivots around the trunnions477 and the rod 470 slides in and out of the bore 472. Since link 416 ispivotally mounted to the gimbal housing 306, the right/left displacementof the link 416 pivots the link 416 about the axis through bearings 422.This pivoting of the link 416 forces guide post 334 to engage in a likeright/left movement. The displacement of the guide post 334 results inopposed left/right pivoting of the bur head 204.

The lead screw threaded portion 439 and complementary yoke nut 476 havea fine pitch and lead angle to prevent backdriving (i.e. it isself-locking). As a result, a large load placed on the bur head 204 doesnot result in undesired back driving of the yaw motor 222. In oneembodiment of the invention, the lead screw 436 is identical to leadscrew 336.

Magnets 480 are mounted in a pair of pockets (not identified) defined inan outside surface of one of the arms 418. A rectangular plate 484 ismounted to the arm 418 by a pair of fasteners (not identified). Plate484 holds magnets 480 in the pockets. Magnets 480 are mounted to the arm418 so that the north pole of one magnet 480 and the south pole of thesecond magnet 480 both face the plate 484. The magnets 480 are used toestablish the home position for the cutting accessory 202 along theY-axis.

A bracket 488 is fixed to the carrier 302 with fasteners 490. Bracket488 is mounted to the top surface of the carrier base 305. The center ofbracket 488 is open. The 488 bracket is formed to have two pockets,pocket 394 and pocket 494. Pocket 394 is located immediately abovecarrier base 305. Pocket 494 is spaced further above the carrier base305. Upon assembly of surgical instrument 200, motor 206 is seated inand extends through bracket 488. The arms 318 and 418 of, respectivelylinks 316 and 416, are both located outside of bracket 488. The link arm318 that holds magnets 380 is located adjacent pocket 394. The link arm418 that holds magnets 480 is located adjacent pocket 494. Hall-effectsensors 392 and 492 are mounted in pockets 394 and 494, respectively.The signal from Hall-effect sensor 394 varies as a function of theproximity of magnets 380. The signal from Hall-effect sensor 494 variesas a function of the proximity of magnets 490.

The analog signals output by Hall-effect sensors 392 and 492 are appliedto, respectively, motor controller 230 and motor controller 232. Eachmotor controller 230 and 232 has an analogue to digital converter, (notillustrated) to which the associated analogue Hall sensor signal isapplied. Motor controllers 230 and 232 forward the digitizedrepresentations of the signals from Hall-effect sensors 392 and 492,respectively, to controller 120.

FIGS. 18-27 show various pitch and yaw positions of the cuttingaccessory 202. From these Figures it can be appreciated that lead screw336 is parallel with motor 220. Lead screw 436 is parallel with motor222. This arrangement of the components of instrument 220 minimizes theoverall size of the instrument 200.

C. Handle Assembly

Referring to FIGS. 28 through 37 the handle assembly 500 is nowdescribed. The handle assembly 500 slidably supports carrier 302. Thesliding movement of the carrier 302 results in the linear adjustment ofthe cutting accessory 202 along the longitudinal axis Z (also referredto as a z-axis) of the instrument 200. Handle assembly 500 comprises thehandle 502, a trigger assembly 506, and a linear adjustment mechanism513.

The handle 502 is hollow and defines a cavity 503 in which motor 224 isdisposed. At a top of the handle 502 is a wall 510. A hand-grip portionof the handle 502 descends downwardly from the wall 510. Wall 510 isformed with an opening 505 (identified in FIG. 37) that extends intocavity 503. Handle 502 is further formed to have two steps 509 and 511(seen best in FIG. 50) that are located below opening 505 and thatdefine portions of cavity 503. Step 509, the more proximal of the twosteps, is closest to wall 510. Step 511 extends distally forward fromand is located below step 509. A threaded bore 515 extends downwardlyfrom the base of step 511.

As shown in FIG. 34, elongated rails 508 extend longitudinally along theopposed sides of the top of handle wall 510. Each rail 508 is shaped todefine a groove 512. Handle 502 is formed so that grooves 512 face eachother. Bearing strips or liners 514 fit inside the grooves 512. Thebearing strips 514 are channel-shaped to define the channels 504 toreceive the corresponding carrier flanges 303. The carrier flanges 303are supported in the bearing liners 514 such that the weight of thecarrier 302 is born by the bearing liners 514. The bearing liners 514are preferably formed of a low friction material to facilitate slidingof the carrier flanges 303 in the bearing liners 514. Such materials mayinclude high performance polymers such as iglide® J from Igus, Inc. ofEast Providence, R.I. Screws 517 hold the bearing liners 514 in positionby engaging flats in the liners 514 at the screw locations (not shown).

Carrier 300, handle 502 and liners 514 are collectively designed so thatwhile carrier flanges 303 are able to slide back and forth in the liners514, there is ideally no up/down or right/left movement of the carrier300 relative to the handle 502. Specifically the handle 502 and liners514 are designed so that the outer diameter of the liners 514 isslightly less than the diameter of the rail grooves 512 in which theliners 514 are seated. In some versions of the invention, the diameterof rail grooves 512 is between approximately 0.02 to 0.12 mm more thediameter of liners 514. Liners 514 have an outer diameter ofapproximately 4.78 mm. The distance between the opposed faces of theliners 514 against which the carrier flanges 303 seat is also slightlyless than distance between the opposed outer faces of the flanges 303.This difference may be between approximately 0.05 and 0.15 mm. Thesefeatures collectively minimize the up/down and right/left play of thecarrier flanges 303 in the liners 514.

Handle 502 has two spaced apart coaxial sleeves 523, identified in FIG.36, that are integral with and located above wall 510. One sleeve 523extends forward from the proximal end of the wall 510. The second sleeve523 extends proximally rearward from the distal end of the wall 510.Each sleeve 523 is formed to have a bore 524.

Referring to FIG. 36, the linear adjustment mechanism 513 includes alead screw 516 that is rotated by motor 224. Screw 516 has opposingfirst and second stems 518 and 520, respectively that are cylindrical inshape. Screw 516 has a threaded body 519 located between stems 518 and520. Bearings 522 rotatably hold lead screw 516 to sleeves 523. Twobearings 522 are disposed over each screw stem section 518 and 520. Eachpair of bearings 522 is located in one of the sleeve bores 524. Endplugs 526 and 528 are threaded into internal threads in the bores 524 tosecure the bearings 522 and lead screw 516 to the handle 502. (Borethreading not illustrated) End plug 526 is disposed in the distal end ofdistal most sleeve 523. End plug 528 is disposed in the proximal end ofthe proximal sleeve 523.

Inside bearings 522, bushings 530 and 532 are disposed about the screwstems 518 and 520, respectively. Bushing 530 has an annular, outwardlyextending flange 534 that abuts an end of the threaded body 519 of thelead screw 516. Bushing 532 is integrally formed with a bevel gear 536that is located on the proximal end of the bushing. The bevel gear 536is fixed to the screw stem 520 by set screws (only one shown). The bevelgear 536 has teeth that mate with teeth on another complimentary bevelgear 540. The complimentary bevel gear 540 is fixed to an output shaft542 of motor 224 by set screws, (not identified). The bevel gears 536,540 are positioned such that their corresponding teeth mate to rotatelead screw 516 upon actuation of motor 224.

A mounting bracket 546 secures the motor 224 in the handle 502 withfasteners 548. In particular, the handle 502 has an arcuate recess 550(as shown in FIG. 49) in the cavity 503 for receiving a portion of thecylindrically shaped outer wall of the motor 224. Mounting bracket 546is arcuately shaped to seat over the portion of motor 224 that extendsaway from the adjacent internal surfaces of the handle 502.

A nut 552 is disposed in carrier slot 317, seen in FIG. 35A. Nut 552 hasa center cylindrical body (not identified) from which two wings 557(identified in FIG. 38) extend. The nut 552 is formed so that wings 557have a coplanar face. A portion of this coplanar face extends across thebody of the nut 552. The nut 552 is positioned so that the wings 557 aredisposed against the face of the carrier base 502 on the opposed sidesof slot 317. Fasteners 553 (FIG. 35B) extend through openings in wings557 and complementary openings in the carrier base 305 to hold the nut552 to the carrier 302 (nut and carrier openings not identified). Thenut 552 has internal threads that mate with threads on the lead screw516. Since nut 552 is firmly attached to the carrier 302 it should beappreciated that the nut 552 does not rotate. Consequently, the rotationof the lead screw 516 results in the movement of the nut 552 and, byextension, the carrier 302 and attached components, relative to handle502.

As the nut 552 travels along the lead screw 516, the carrier flanges 303are able to freely slide in the bearing liners 514. The entire mass ofthe upper assembly 300 moves relative to the handle 502 duringdisplacement of nut 552 along the lead screw 516. The lead screw 516 hasfine pitch and lead angle to prevent backdriving (i.e. it isself-locking). As a result, a large load placed on the bur head 204 willnot result in undesired back driving of the axial motor 224. In oneembodiment, the lead screw 516 is of the same diameter as and has thesame lead as screws 336 and 436.

A magnet holder 560, now described by reference to FIGS. 35 and 35B, isdisposed in handle cavity 503. Magnet holder 560 is a single piece unitthat includes a beam 559 and a foot 561 located below the beam. Foot 561has a length relative to the beam 559 such that the proximal end of thefoot 561 is located forward of the proximal end of the beam 559 and thedistal end of the beam 559 is located rearward of the distal end of thebeam 559. A closed end bore 563 (one identified) extends through eachend of beam 559. Bores 563 open from the underside of beam 559 and havelongitudinal axes that are perpendicular to the longitudinal axis of thebeam 559. When instrument 200 is assembled, the proximal end of magnetholder beam 559 seats on handle step 509; foot 561 seats on step 511. Afastener 565 extends through the beam 559 and step 511 into handle bore515 to secure magnet holder 560 to the handle 502. A magnet 556 ismounted in each holder bore 563. Magnets 556 are mounted to holder 560so that the north pole of one magnet 556 and the south pole of thesecond magnet 556 are both directed to the carriage 302.

A plate 564 is fixed to the nut 552 with the same fasteners 553 thatmount the nut 552 to the carrier 302. Plate 564 is disposed against thecommon planar outer face of nut wings 557. A Hall-effect sensor 566 isseated in a pocket 567 formed in plate 564. Sensor 566 outputs a signalthat is function of the proximity of the sensor 566 to magnetic fieldsgenerated by magnets 556. The analog signal output by sensor 566 isapplied to controller 234. Controller 234 digitizes this signal andforwards the digitized signal to the instrument controller 120.

The trigger assembly 506 includes the trigger 208. The trigger 208slides in a trigger housing 570. The trigger housing 570 is mounted tothe handle 502 with fasteners (not identified). The trigger 208 has ahead (not identified) shaped to be pressed by a finger of the user. Astem 574 extends rearward from the trigger head.

Trigger stem 574 is located inside a bore 576 in a trigger shaft 578. Aset screw holds the stem 574 inside the trigger shaft 578. The triggershaft 578 has a generally cylindrical head 580 sized to slide within alarger bore 582 of a trigger housing 570. The head 580 has a rib 584 ata top thereof. The rib 584 is formed on a flat of the head 580. The rib584 extends upwardly into a corresponding groove 588 defined inside thetrigger housing 570 as an extension of the bore 582. The rib 584 slidesin the groove 588 to prevent rotation of the trigger shaft 578 relativeto the trigger housing 570.

A spring pin 594 is located in a cylindrically-shaped pocket 590 of thehandle 502. In particular, the spring pin 594 has a head 592 located inthe pocket 590. A pin shaft extends forward from the head 592 into acorrespondingly shaped bore 598 in the trigger shaft 578. A spring 600is at least partially positioned in the bore 598. The spring 600 islocated between an internal end wall of the trigger shaft 578 and thehead 592 of the spring pin 594. The spring 600 biases the trigger shaft578 away from the handle 502.

The trigger shaft 578 further defines a magnet pocket on an undersidethereof. A magnet 606 is secured in the magnet pocket preferably withadhesive. The trigger housing 570 also defines a sensor pocket oppositethe groove 588.

A Hall-effect sensor 610 is secured in the sensor pocket preferably withadhesive. The Hall-effect sensor 610 transmits a variable signal back tothe instrument controller 120 based on the distance of the magnet 606from the Hall-effect sensor 610. Accordingly, the instrument controller120 can determine the amount of depression of the trigger 208 by theuser. The data connection 133 transmits not only power signals andcontrol signals between the motor 206 and the instrument driver 130, butalso transmits signals from the Hall-effect sensor 610 to the instrumentconsole 130.

FIGS. 37-39 show various Z-axis positions of the nut 552 (and carrier302) along the axis Z with respect to the handle 502.

D. Wire Fittings

As now described by reference to FIGS. 40 through 45, carrier 302includes a number of bores through which wires are routed. These wires(not illustrated) are the wires over which sensor signals are receivedfrom and power signals are applied to the various components mounted tothe carrier 302. Carrier base 305 defines a pair of longitudinal throughbores 612. Each through bore 612 is located above and inwardly of aseparate one of the flanges 303. A guide tube 614, preferably formed ofplastic, is located inside each through bore 612. The lumen 615 internalto one tube 614 functions as the conduit for the eight wires that extendto motor 220. The lumen 615 through the second tube 614 functions as thelumen for the eight wires connected to motor 222. During assembly, theguide tubes 614 are inserted into one end of the bores 612. A plug tube616 closes the opposed end of each bore 612. Each guide tube 614 has afirst end disposed in the associated bore 612 and a second end with ahead 618 that abuts the proximally directed face of carrier base 305. Asseen in FIG. 44, each guide tube 614 is shaped so that at the distalend, the end disposed in carrier bore 612 there is a foot 617. The foot617, which has the same arcuate dimensions as the body of the tube 614has a surface coincident with the inner surface of the body of the tube614 (surface not identified). Extending distally forward from the end ofthe tube body, this foot surface curves downwardly.

Two holes 620 extend downwardly from the top face 311 of carrier base305. Holes 620 are oval in cross sectional shape. Each hole 620 islocated inwardly of and does not intersect an adjacent bore 612. Carrierbase 305 is further formed to have two opposed pockets 636. Each pocket636 extends inwardly from a side face 313 of the carrier 302. Eachpocket 636 intersects one of the through bores 612 and the adjacent hole620. A plastic sleeve 622 is seated in each hole 620. Each sleeve 622has a tubular body 630 dimensioned to slip fit in the hole 620. Sleevebody 630 has a through bore 632. A flange 628 extends radially outwardlyfrom the upper end of the body 630. The flange 628 seats in acounterbore around hole 620 to hold the sleeve 622 flush with carrierbase top face 311. A plug 624 is seated in each pocket 636. Each plug624 is formed with a mid bore 634. When a sleeve 622 and adjacent plug624 are fitted to the carrier base 305 the plug midbore 634 is alignedwith the sleeve bore 632. A pair of sleeves 626 are also mounted tocarrier 302. Each sleeve 626 is seated in a bore (not identified) thatextends upwardly from one of the bottom face surfaces 315 of the carrier302. Each sleeve 626 is adjacent and located inward of the associatedcarrier bore 620. Each sleeve 626 is also positioned to intersect theassociated bore 612. The outer face of sleeve 626 is flush with thebottom face 315 of the carrier base 305. Each sleeve 626 is formed tohave a bottom bore 638 aligned with the top bore 632 and the mid bore634. The plugs 622, 624, 626 are held in position by adhesive and/orpress fit. All of the plugs 622, 624, 626 are preferably made fromplastic.

FIGS. 46-50 illustrate the void spaces internal to the handle 502through which the wires are routed through the handle 502. These voidspaces include a pair of wire troughs 640. Troughs 640 are parallelrecesses that extend inwardly from wall 510 in the top of the handle502. Each trough 640 holds a bundle of wires that extend to the carrier302 (wire bundles not illustrated). The wire bundles include the wiresthat extend to the instrument motor 206, the motors 220 and 224 thatpivot the cutting accessory 202 and the Hall effect sensors 392, 492,and 566.

The wires that extend through to the carrier 302 as well as the wiresassociated with trigger 208 and motor 226, extend through handle cavity503. A wire sorter 642, now described with reference to FIGS. 52, and53, disposed in the cavity 503 holds the wires static. Referring to FIG.53, the wire sorter 642 has a head 650 dimensioned to slip fit in thehandle cavity 503. Head 650 is disposed on a plane that is perpendicularto the longitudinal axis through the cavity 503. A number of openings644 extend top to bottom through the head 650. Openings 644 function asconduits through which individual wires and wire bundles pass throughthe cavity 503. A threaded retainer 648 and ferrule 646 are positionedin each opening 644. Legs 652 extend downwardly from the head 650. Inthe depicted version of the invention, in the plane perpendicular to thetop-to-bottom axis through the head 650, the head 650 is oval in shape.The legs 652 extend downwardly from the opposed parallel sides of thehead 650. A foot 654 extends outwardly from the free end of each of thelegs 652. Wire sorter feet 654 are adhesively secured to an inner steparound the bottom end shell lid 674 (FIG. 54) so as to set the positionof the sorter head 650 in the handle cavity 503.

Wire Sorter 642 provides strain relief for the wire bundles runningthrough the handle 502. The ferrules 646, which are formed of plastic,hold the wire bundles in place. The ferrules 646, best seen in FIG. 53A,are compressed inside the sorter openings 644 via a tapered front andthrust provided on the tapered front by the threaded retainers 648. Eachferrule 646 is slotted along its entire length such that it compressesdiametrically as the threaded retainer 648 forces the ferrule's taperedtip into its tapered hole. While not called out in drawings, thediameter of each ferrule 646 is proportional to the diameter of theopening in which the ferrule 646 is seated.

E. Shell

Referring to FIG. 54, the shell 670 is mounted to a bottom of the handle502. The shell 670 houses the controllers 230, 232, 234. Shell 670includes a rectangular case 676 in which the controllers 230, 232 and234 are disposed. Case 676 is open at the top. A lid 674 is secured overthe open top end of the case 676. Lid 674 is mounted to the bottom ofthe handle 502 with fasteners 672. Internal to the case are standoffs675 that are post-like in shape. Controllers 230, 232 and 234 arestacked one on top of the other in the case 676. One set of standoffs675 hold the bottommost controller away from the bottom of the case 676.A second set of standoffs hold the middle controller away from thebottommost controller. A third set of standoffs 675 hold the topmostcontroller away from the middle controller. The wires from the motors220, 222, 224 and Hall effect sensors 392, 492, 566 terminate at thecontrollers 230, 232 and 234.

In alternative embodiments, the controllers 230, 232, 234 are mounted inthe control unit 120 and not on the instrument 200. These embodiments ofthe invention do not include shell 670.

F. Tracker Bracket

Referring to FIG. 55, the bracket assembly 700 is mounted to the handle502 to hold the tracking device 114 if needed. In alternativeembodiments, the LEDs of the tracking device 114 are built into theinstrument 200 eliminating the need for the bracket assembly 700.

Bracket assembly 700 includes a generally U-shaped bracket 701. Bracket701 has a pair of parallel mounting arms 702 that extend downwardly froma web 704. An end of each mounting arm 702 is aligned with the handle502 by alignment pins 706. Fasteners 708 hold the mounting arms 702 tothe handle 502. The tracking device 114 is designed to be fixed to thehandle 502.

Bracket web 704 is formed with a threaded bore 710. A block 712 isdisposed over web 704. A threaded fastener 716 extends through a bore713 in block 712 and into web bore 710. Fastener 716 holds block 712 tobracket 701 so that the block 712 is able to rotate around the axisthrough web bore 710. Fastener 716 is longer in length than block 712. Awasher 718 is located immediately below the head of fastener 716(fastener head not identified). To lock block 712 in a fixedorientation, fastener 716 is tightened down so that the block 712 isclamped between bracket web 704 and washer 718.

To adjust the orientation of block 712, fastener 716 is loosened. Aspring 720 extends around fastener 716 below washer 718. The opposed endof the spring 720 seats against a step (not illustrated) internal toblock 712 that is inside the block bore 713. When fastener 716 isloosened to adjust the rotational orientation of block 712, spring 720is in a compressed state between washer 718 and the step internal to theblock 712. This compressive force inhibits the free rotation of block712 when fastener 716 is loosened.

While not illustrated, in some versions of the invention, bracket web704 is formed with arcuately spaced apart teeth that radiate outwardlyfrom bore 710. The adjacent bottom surface of the block 712 is formedwith complementary teeth. As part of the position of setting therotational position of the block 712, the block 712 is set so that theblock teeth are interleaved between the complementary teeth in thebracket web 704. This tooth-against-tooth engagement serves to furtherprevent rotational movement of the block 712 when in the locked state.

A second block, block 722 is rotatably attached to block 712. Block 722is positioned to abut a side face, face 714 of block 712. Block 722 isformed with a through bore 723 that extends axially through the block722. Block 712 is formed with a second bore, (not illustrated) thatextends inwardly from the center of face 714. This second bore isperpendicular to block bore 713. A fastener 726, similar if notidentical to fastener 716 extends through block bore 723 and into thesecond bore of block 712. Fastener 726 holds block 722 to block 712 sothat block 722 can rotate around the fastener 716. A washer 728 islocated between the head of the fastener 726 and block 722. Thetightening of fastener 716 causes block 722 to be clamped between block712 and washer 718.

While not illustrated, blocks 712 and 722 are formed with complementaryteeth. The teeth integral with block 712 extend radially outwardly fromthe bore formed in block face 714. The teeth integral with block 722 areformed in the face of the block 722 that seats against block 712. Aspart of the process of fixing the rotational orientation of block 722,the block 722 is rotated so that the teeth integral with block 722engage between the teeth formed in face 714 of block 712. Thistooth-between-tooth engagement further locks block 722 to block 712.

A spring 730 is disposed around fastener 726. Spring 730 from washer 728extends into block bore 723. Spring 730 seats against a step internal toblock bore 723. When fastener 726 is loosened, spring 730 imposes aforce on block 722 that inhibits the free rotation of block 722.

Block 722 is further formed with a second bore, bore 724. Bore 724extends through one of the side faces of the block 722 toward bore 723.A fitting 732 is press fit into bore 724. Fitting 732 is provided withfeatures not relevant to the current invention that facilitate theremovable attachment of a tracker to the fitting 732.

Block 712 rotates around a longitudinal axis between bracket arms 702.Block 722 rotates around an axis perpendicular to the axis around whichblock 712 rotates. Thus this arrangement allows the position of trackerattached to fitting 732 to be selectively positioned around tworotational degrees of freedom. This facilitates the ability to orientthe tracker to ensure good line-of-sight with the camera 110 of thenavigation unit 108.

In the depicted version of the invention, one bracket arm 702 isprovided with a threaded bore 730. The second arm 702 is provided with athreaded bore 740. Bores 730 and 740 are both designed to receivefastener 716. While not illustrated, the bracket arms 702 are providedwith teeth around bores 730 and 740 similar to the teeth provided aroundweb bore 710. Thus, these structural features make it possible to mountblocks 712 and 722 to either one of the bracket arms 702. This makes itpossible to mount the tracker to either of the bracket arms 702 if suchpositioning facilitates the optimal positioning and orienting of thetracker to ensure a line of sight relationship with the localizer.

IV. Registration, Calibration and Homing

Referring to FIG. 58, the basic steps taken to prepare the system foroperation are shown (the system is considered to be the tracking andcontrol system 100 and instrument 200). In a first step 800, the systemis powered up. The software application for operating the system isstarted in step 802. In steps 804 and 806, the trackers 114, 116 and thepointer (not shown) are initialized and the trackers 116, 114 are placedon the target bone (e.g., femur 102) and the instrument 200.

With the tracking device 116 mounted to the femur 102, the femur 102(and any other bone or tissue) is registered in step 808 usingregistration techniques known to those having ordinary skill in the art.This may require the user to touch certain surfaces or landmarks on thefemur 102 with a tracked pointer device. In some embodiments thisrequires the user to touch several points on the surface of the femur102 while pressing a select button on a pointer device. This “paints”the points on the surface in the system for matching with a preoperativeor an intraoperative image of the femur 102. The preoperative image oran intraoperative image of the femur 102 is loaded into the navigationcomputer. The tracked portion of the femur 102 is registered to thepreoperative image. By extension, this allows the tracking and controlsystem 100 to, as the femur 102 moves, present an image of the actualposition and orientation of the bone based on the preoperative image onthe display 113 (and/or display 1402).

In step 810 the work boundary 106 is defined. Software running oninstrument controller 120 generates an initial definition of the workboundary 106. The user typically has the ability and option to adjustthe placement of the work boundary 106 as may be necessary. In someembodiments, the work boundary 106 is defined before the operation suchas after the preoperative image is taken and a 3-D model of the femur102 or other tissue is generated, but before the patient is prepared forsurgery. Thus, the work boundary 106 may be defined preoperatively orintraoperatively.

In the calibration procedure in step 812, the orientation and locationof the tracking device 114 is calibrated relative to the handle 502 byreference to the fixed and known locations of divots 507 (FIG. 3). Inthe embodiments in which the tracking device 114 is integrated into theinstrument 200, then such calibration would be unnecessary since therelative locations of the LEDs or other transmitters are known.

The pointer device is used to register the target bone 102 to trackingdevice 116.

Referring to FIGS. 56 and 58, a homing procedure of step 814 establishesthe home position for the accessory distal end bur head 204, the distalend of the bur head. This process establishes the initial positions ofthe carriage 302 and links 316 and 416. Initially in this process, thecounters internal to the controllers 230, 232 and 234 that store thecumulative counts representative of the angular positions of rotorsinternal to motors 220, 222 and 224 are set to zero.

The process by which carriage 302 is set in the home position along theaxis Z is described first. At a beginning step of this process,controller 120 directs motor controller 234 to actuate the associatedmotor 224. First, motor 224 is actuated to rotate lead screw 519 so asto cause the forward, distal, displacement of carriage 302. During thistime period, motor controller 234 monitors the signals from theHall-effect sensors internal to the motor 224. The controller 234maintains the count in the counter that is representative of the totaldegrees of rotation of output shaft 542. In some constructions of theinvention, each incremental count associated the rotation of the motorrotor that results in the distal displacement of the motor rotor is apositive incremental count. Each incremental count associated with therotation of the rotor resulting in the proximal movement of the carriageis a negative incremental count. As a result of the displacement of thecarriage 302, sensor 566 is advanced towards the distal of the twomagnets 556 mounted to the handle 502. As a result of the movement ofthe sensor 566 towards the distal magnet 566, the output signal from thesensor changes.

During this displacement of the carriage 302, controller 234 forwards tocontroller 120 the digitized representation of the signal output byHall-effect sensor 566. Also forward from controller 234 to controller120 during this process is the cumulative count data representative ofthe rotational position of the motor rotor.

Controller 120 compares the data from the counter integral withcontroller 234 to a first threshold value. This first threshold value isa signal level representative of the signal Hall-effect sensor 566outputs when the sensor 566 is in a defined position along handle 502.This position of the carriage 302 can be considered the distal homingposition. When the signal from sensor 566 reaches this first thresholdlevel, controller 120 directs controller 234 to terminate theapplication of energization signals to the motor 224. This stops thedistal advancement of the carriage 302. Controller 120 stores thecurrent cumulative count value from the counter.

Controller 120 then directs motor controller 234 to apply energizationsignals are then applied to motor 224 to cause the motor to displacecarriage 302, proximally. During this displacement of the carriage 302,controller 234 generates negative incremental counts representative ofthe degrees through which the rotor is rotated. These negative counts,when applied to the counter, cause the cumulative count to decrease. Thecumulative count stored in the counter may decrease to zero or to anegative number. During this displacement of the carriage 302, motorcontroller 234 again forwards the digitized representations of theoutput signal from Hall-effect sensor 566 and the data in the counter tocontroller 120.

The motor 224 is actuated so as to cause carriage 302 to move alonghandle 502 to a proximal homing position. As a consequence of thedisplacement of carriage 302, the signal output by the Hall effectsensor 566 changes levels as it moves away from the distal magnet 556and toward the proximal magnet 556. Controller 120 compares the signalfrom Hall-effect sensor 566 to a second threshold level. This secondthreshold level is the level of the signal sensor 566 outputs when thecarriage 302 is in the proximal homing position. When the signalcomparison indicates that the carriage 302 is in the proximal homingposition, controller 120 instructs controller 234 to terminate actuationof the motor 224. At this time, controller 120 also stores the countdata from the counter internal to the controller 234.

At this time, the controller 120 has stored as data the cumulativecounts representative of the angular position of the motor rotor neededto displace the carriage 302 first to the distal homing position andthen to the proximal homing position. The absolute difference betweenthese two counts is calculated. This difference is divided by two. Thisvalue represents the number of counts, through which the rotor integralwith motor 234 must be cycled from its current position in order tocenter carriage 302 to the home position on handle 502. For example, inthis process, computer may receive indication that: when the carriage302 was in the distal homing position, the count value was 250; and whenin the proximal homing position, the count value was −148. Thedifference between these count values is 398. One half this differenceis 199.

Once this displacement count is calculated, controller 120 adds thevalue to the current count value. In the present example −148+199=51.This number is referred to as a target position. During the homingprocess, this target position is a positive or negative number equal tothe cumulative count representative of the angular position the rotorintegral with motor 234 should rotate to cause the displacement ofcarriage 302 to the axis Z home position. Controller 120 forwards thistarget position to motor controller 120. The motor controller 234 inturn, applies energization signals to the motor 224 so as to cause therotor to rotate towards this count represented by the target position.During the resultant rotation of the motor rotor, the changing values ofthe motor Hall-effect sensors result in the output of counts that resultin the incremental increase of the count value stored in the controllercounter.

During this step, motor controller 234 compares the cumulative countstored in the counter to the count represented by the target position.When these two values are equal, controller 234 terminates theapplication of energization signals to motor 224. It should beunderstood that this rotation of the motor rotor and, by extension, leadscrew 516 results in the displacement of carriage nut 552 along the leadscrew 516. This movement of nut 552 is what moved the carriage 302 andthe cutting accessory 202 to their home positions along the axis Z.

Motors 220 and 222 are actuated in a like manner to position the cuttingaccessory 202 in the home positions along the X- and Y-axes.Specifically, motor 220 is actuated to pivot link 316 between opposedupper and lower homing positions. During this process, the signal fromHall-effect sensor 392 varies as a result of the displacement of magnets380. The digitized representation of this Hall signal as well as thecount value from controller 230 is output to controller 120. The signalfrom Hall-effect sensor 392 is compared between two threshold signallevels to determine when the link 316 reaches the threshold positions.The differences in the cumulative counts from the motor rotor when thelink 316 is in these two positions is determined. The difference incumulative counts is divided in two. The resultant quotient is added tothe current count value to produce a target position. This targetposition is a positive or negative number equal to a targeted cumulativecount. This targeted cumulative count is proportional to the angularposition to which the motor rotor needs to be rotated to in order causethe movement of link 316 to its home position.

The target position is output from controller 120 to controller 230.Controller 230 applies energization signals to the motor 220 thatresults in the rotation of the motor rotor. This rotation of the rotorresults in the count maintained by the counter internal to thecontroller 230 reaching the cumulative count of the target position.Once the controller 230 determines the cumulative count equals thetarget position, the controller 230 terminates the application ofenergization signals to the motor 220. The rotation of the lead screw336 and resultant displacement of nut 376 cause link 316 to pivot to itshome position. This pivoting of the link 316 to the home position, inturn, causes the like pivoting of the cutting accessory 202 to its homeposition along the X-axis.

To move cutting accessory 202 to its home position on the Y-axis, motor222 is actuated to pivot link 416 between opposed right and left homingpositions. During this process, the signal from Hall-effect sensor 492varies as a function of the movement of magnets 480 to/from the sensor492. During this homing process, controller 232 provides controller 120with: the digitized representation of the output signal from Hall-effectsensor 492; and the count value maintained by the controller 232 as aresult of the rotation of the motor rotor. By way of example, motor 222is initially actuated to cause link 416 to first pivot to the lefthoming position. Controller 120 compares the signal from Hall-effectsensor 492 to a first threshold level. This comparison is performed todetermine when link 416 reaches the left homing position. Motor 222 isthen actuated to pivot the link 416 towards the right homing position.Controller 120 recognizes that the link 416 is in this second homingposition when the signal from Hall-effect sensor 492 reaches a secondthreshold level.

Controller 120 then computes the difference in count values from whenthe link 416 was in the right and left homing positions. This differencein count values is divided by two. The resultant quotient is added tothe present cumulative count. This sum is a count value representativeof the angular position to which the rotor integral with motor 222 needsto rotated to center link 416 in its home position. This count value isadded to the current count value associated with the rotor integral withmotor 222. Controller 120 outputs this target position to controller232.

In response to receipt of this target position, controller 232 appliesenergization signals to the motor 222 that result in the rotation of therotor. More specifically, the rotor is rotated so that the Hall-effectsensors integral with motor 222 output counts that result in theincrementing or decrementing of the cumulative count to the targetposition. Once controller 232 determines that the cumulative countequals the target position, the computer terminates the application ofenergization signals to motor 222. During this process, the rotation ofthe motor rotor and lead screw 436 resulted in the displacement of nut476 and the pivoting of link 416. The link 416 is pivoted to its homeposition which results in a like pivoting of the cutting accessory 202to the cutting accessory home position along the Y-axis.

Each controller 230, 232 and 234 informs controller 120 of when thecount of the rotor associated with the controller reaches the targetposition. Controller 120 accepts these state data as an indication thatthe cutting accessory 202 is in the home position. Once the cuttingaccessory 202 is centered on the X-, Y- and Z-axes, controller 120 zerosout the counters internal to the motor controllers 230, 232 and 234 thatmaintain the rotor count values.

Once the cutting accessory 202 is in the home position, a navigationpointer may be used to determine the location of the distal end of thecutting accessory 202, bur head 204. Thus, the system 100 knows theposition of the bur head 204 in the home position and its relation tothe position and orientation of the hand-held portion. Accordingly, whenthe hand-held portion is moved by the user and its position andorientation is tracked using tracker 114, the system 100 also tracks theposition of the bur head 204. In other versions of the invention, as aresult of prior calibration processes, the position of the distal end ofthe cutting accessory 202 relative to the instrument 200 is assumed tobe known.

Once registration, calibration, and homing (if used) are complete, thenavigation unit 108 is able to determine the spatial position of the burhead 204 with respect to the target bone 102 and the target volume 104.The instrument 200 is ready for boundary constrained cutting of thetarget volume of material 104 in step 816.

V. Instrument Control

After the homing process, control by controller 120 of the instrument200 are based on (1) the position and orientation data from thenavigation computer 112; (2) the cumulative count data from controllers230, 232, 234; and three signals indicating the extent to which trigger208 is actuated.

As represented by FIG. 56, surgical instrument 200 is designed to allowthe displacement of the cutting accessory 202 that results in thedisplacement of bur head 204 in each of the X- (pitch), Y- (yaw) andZ-axes by at least +/−0.2 inches (+/−0.508 cm). Said differently, thedistal tip or bur head 204 of the working portion is capable of a totaldisplacement of at least 0.4 inches (1.016 cm) in each of the pluralityof degrees of freedom. In another embodiment, for example, the distaltip of the working portion, e.g., the bur head 204, is capable of atotal displacement of at least 0.2 inches (0.508 cm), i.e., +/−0.1inches (+/−0.254 cm) in each of the plurality of degrees of freedom. Inother embodiments, for example, the distal tip of the working portion iscapable of total displacement of at least 0.5 inches (1.27 cm), i.e.,+/−0.25 inches (+/−0.635 cm); at least 1.0 inches (2.54 cm), i.e.,+/−0.5 inches (+/−1.27 cm); at least 1.5 inches (3.81 cm), i.e., +/−0.75inches (+/−1.905 cm); at least 2.0 inches (5.08 cm), i.e., +/−1.0(+/−2.54 cm); at least 2.4 inches (6.096 cm), i.e., +/−1.2 inches(+/−3.048), or at least 3.0 inches (7.62 cm), i.e., +/−1.5 inches(+/−3.81), or more. In many versions of the invention, the displacementof the bur head 204 along the X axis is equal to the displacement alongthe Y axis which is equal to the displacement along the Z axis.

The normal operating position of the cutting accessory 202 is the homeposition. The range-of-motion data provided above is given with respectto the bur's center. In many versions of the invention, when the burhead 204 is in the home position, the bur head 204 is able to travel anequal distance, up/down, right/left, proximal/distal along axis,respectively the X-, Y- and Z axis. If the potential displacement of thebur head 204 is equal along each axis, the bur head 204, when in thehome position can be considered to be in the center of the sphere thatrepresents the range of motion defined by the control system 100. Theouter perimeter of the sphere is the outer perimeter of the potentialmovement of the bur head 204 away from the home position. As discussedbelow instrument controller 120 moves the bur head 204 away from theconstraint boundary 111 when the bur head 204 intersects or crosses theboundary 111. This deflection could be along any one, two or three ofthe axes along which the cutting accessory 202 can be displaced.

Referring to FIG. 59, a sample flow chart of steps taken by theinstrument controller 120 to control the instrument 200 is shown. Instep 900, the latest positions of the target bone 102 and the instrument200 are transmitted from the navigation computer 112 to the instrumentcontroller 120 over the data connection 121. Using these data, theinstrument controller 120 determines the locations of the workingboundary, the constraint boundary 111 and bur head 204 in free space,step 902. As part of step 902, the relative location of the bur head 204to the constraint boundary 111 is also computed. In step 904 theinstrument controller 120 updates the navigation GUI (display 113) withthe position of the bur head 204 relative to the tissue to which the burhead 204 is applied. An indication of the location of the workingboundary 106 may also be presented.

Regardless of the location of the bur head 204 to the constraintboundary 111, when the bur head 204 is pressed against tissue, the burhead 204 is exposed to the resistance of the tissue. This resistance isin opposition to the force the practitioner places on the bur head 204as a result of the practitioner moving the instrument 200 forward. Theresistance of the tissue essentially is a force imposed on the cuttingaccessory 202 in opposition to the forward force placed on the cuttingaccessory 202 by the practitioner. This force is significant when thetissue is a hard unyielding tissue such as bone.

As discussed above, lead screws 336, 436 and 516 and complementary nuts376, 476, and 552, respectively, are finely threaded. This finethreading prevents the displacement of the associated nut 376, 476 or552 when force is placed on the nut that is parallel to the longitudinalaxis of the lead screw. By way of example, if the bur head 204 ispressed against a bone face so that the longitudinal axis of the cuttingaccessory 202 is normal to the bone face, the resistance of the bonebecomes a back force against the cutting accessory 202. This back forceis transferred through coupling assembly 207 and gimbal 304 to thecarriage 302. By extension, this back force attempts to push carriagenut 552 proximally rearwardly. However, the fine pitch engagement of nut552 over lead screw 516 inhibits, locks out, this proximal displacementof nut 552. This locking out of nut 552 from rearward movement resultsin a like locking out of rearward movement by carriage 302 and,therefore, the cutting accessory 202. It should likewise be appreciatedthat this locking out of the movement of lead screw 516, likewiseinhibits back driving of the output shaft 542 or rotor of motor 224.

Similarly, the fine pitch engagement of nut 376 over lead screw 336locks out unintended displacement of cutting accessory 202 along theX-axis. The fine pitch engagement of nut 476 over lead screw 436 locksout unintended displacement of cutting accessory 202 along the Y-axis.Again this locking out of the lead screws 376 and 476 prevents the backdriving of, respectively, motors 220 and 222.

In step 906, the relative location of the centroid of the bur head 204to constraint boundary 111 is evaluated by the controller 120 todetermine if action needs to be taken, i.e., moving the bur head 204,changing the rotational speed of the bur head 204, stopping the bur head204, etc. Display 1402 (see below) can also be updated by the instrumentcontroller 120.

As depicted by step 908, instrument controller 120 sends instructionaldata packets to the motor controllers 230, 232 and 234. Theseinstructional data packets include the target position for the rotor ofthe motor 220, 222 and 224 with which the controller is associated.Here, each target position is positive or negative number representativeof a targeted cumulative count for the associated motor rotor. Thistargeted cumulative count is proportional to a target angular positionfor the motor rotor from the home position for the rotor integral withthe motor 220, 222, or 224 controlled by the controller.

Instrument controller 120 generates and sends these instructional datapackets to each motor controller 230, 232 or 234 at the rate one packetevery 0.5 to 4 milliseconds. In many versions of the invention, eachcontroller 230 and 232 and 234 receives an instruction packet at leastonce every 2 milliseconds.

As represented by step 910, instrument controller 120 also selectivelyregulates the speed of the instrument based on the relative location ofthe bur head 204 to the constraint boundary 111.

In step 912, visual feedback is provided to surgeon by a display locatedon the instrument 200 and separately wired to the instrument controller120 with data connection 1002 to transmit and receive data to and fromthe instrument controller 120.

The steps are repeated at step 914.

Referring to FIGS. 60 and 61, the work boundary 106 can be modeled assurfaces (FIG. 60) or volumes (FIG. 61). When surfaces are used to modelthe work boundary 106, the surfaces can be tessellated into triangles,quadrilaterals, NURBS, etc. On the other hand, when the work boundary106 is modeled as volumes, the volumes can be represented by cubicalvoxels or other parallelepiped-shaped voxels.

Referring to FIGS. 62-63, operation of the instrument 200 with respectto the work boundary 106 and constraint boundary 111 is shown. Here,surgical instrument 200 is operated in what is referred to as a passivemode. In the passive mode, system 100 monitors the position of the burhead 204 relative to the working boundary 106. When the bur head 204approaches or intersects this boundary 106 system 100 deflects theposition of the cutting accessory 202 and/or attenuates the speed of themotor 206.

In FIG. 62, bur head 204 is spaced away from the constraint boundary111. At this time controller 120 maintains the bur head 204 in the homeposition. When the surgical instrument 200 is in this state, instrumentcontroller 120 continually sends data packets indicating targetpositions of zero to the motor controllers 230, 232 and 234. Assumingthe cutting accessory 202 is already in the home position, the currentcumulative counts maintained by the controllers 230, 232 and 234 arealready zero. Given that the target positions equal the current zerovalue cumulative counts, controllers 230, 232 and 234 do not actuatemotors 220, 222 and 224, respectively. Cutting accessory 202 is thusheld in the home position.

As the bur head 204 advances against the tissue, the head 204 eventuallycontacts the working boundary 106 as represented by FIG. 63. Instrumentcontroller 120, through connection to the navigation system 108,recognizes that the bur head 204 is in this position as a consequence ofthe determination that the centroid of the bur head 204 has intersectedthe constraint boundary 111. As a consequence of the bur head 204 beingin this position, the instrument controller 120 calculates a newposition, a deflected position, for the bur head 204 that is normal tothe constraint boundary 111. This deflected position is spaced from thehome position. Specifically, using algorithms and other processes, theinstrument controller 120 calculates the deflected position for the burhead 204. This deflected position is calculated with reference to thereference frame of the instrument 200. This deflected position isquantified as a set of distances along the X-, Y- and Z-axes relative tothe home position.

Instrument controller 120 then generates a set of target position countsto which the rotors integral to the motors 220, 222 and 224 must rotateto reposition the cutting accessory 202 at the deflected position. Thetarget motor rotor angular positions are determined based on thefollowing relationships:

1) During the up/down and right/left pivoting of the cutting accessory202, the cutting accessory 202 functions as a lever pivoting about thecenter of gimbal 304. One end of this lever is bur head 204. The opposedend of this lever is the nut 376 or 476. This is because thedisplacement of the nut 376 or 476 is responsible for, respectively, theup/down or right/left pivoting of the cutting accessory 202. There isapproximately a first order relationship between the extent to whicheach nut 376 and 476 needs to be displaced from the home position of thenut in order to pivot the bur head 204 in the X- or Y-axes from its homeposition. In order to displace the cutting accessory 202 along the axisZ, carriage 302 and by extension carriage nut 552 must be displacedforwardly or rearwardly by the same distance. Accordingly, there is alinear relationship between the displacement of nut 552 from its homeposition and the displacement of the bur head 204 along the axis Z. (Asa consequence of the pivoting of the cutting accessory 202, in eitherthe X- or Y-axis, there is some displacement of the bur head 204 fromthe home position in the axis Z. This displacement is accounted for inthe algorithms that are used to determine the individual X-, Y- andZ-axes displacements of the bur head 204 in order to position the burhead 204 in the deflected position).

2) There is a first order relationship between the degrees of rotationof each lead screw 336, 436 and 516 the linear displacement of the nut,respectively, nuts 376, 476, and 552, fitted to the lead screw.

3) There is a first order relationship between the degrees of rotationof the rotor of each motor 220, 222 and 224, and the lead screw,respectively, lead screw 336, 436 and 516 and geared to the rotor.

4) There is first order relationship between the degrees through whichthe rotor of each motor 220, 222 and 224 rotates and the cumulativecount representative of that position that is maintained by theassociated controller 230, 232 and 234, respectively.

Based on the above relationships, once controller 120 determines thedeflected positions for the bur head 204 on the X-, Y- and Z-axes, thecomputer determines the target position for each motor rotor. Controller120 transmits packets to the motor controllers 230, 232 and 234containing these target positions. Based on these targets position, eachmotor controller 230, 232 and 234 applies the appropriate energizationsignals to the associated motor 220, 222 and 224, respectively. Theseenergization signals cause the rotation of the rotor that results in therepositioning of the carriage 302, link 316, and link 416 that displacesthe bur head 204 into the intended deflected position.

In terms of time, it typically takes approximately 40 ms to displace thebur head 204 from the home position to a deflected position that isapproximately 2 cm away from the home position. During this time periodthe practitioner is still applying a forward force on the handpiece 200.Thus, often, rather than the bur head 204 being totally withdrawn awayfrom the surface of the bone to which the bur head 204 is applied, thebur head 204 remains pressed against the bone. However, as a result ofthe deflection of the bur head 204, the bur head 204 only minimally, ifany, crosses the working boundary 106. If the bur head 204 does crossthe working boundary 106, it only goes beyond the boundary 106 by adistance that is within acceptable tolerance levels for the shape towhich the tissue is being formed. Instead, as a result of the deflectionof the bur head 204 along a line perpendicular to the constraintboundary 111, the bur head 204 remains in contact with bone at theworking boundary 106. Thus, while the bur head 204 continues to removetissue, the tissue removed is in the section of the bone from which thepractitioner wants to remove tissue.

When the system 100 is operated in the passive mode, the application ofenergization signals to the motor 206 is jointly regulated by thecontroller 120 and instrument driver 130. Initially, by setting controlson the instrument driver 130, the surgeon establishes a maximum speedfor the motor 206. Throughout the time the system 100 operates in thepassive mode, controller 120 sends instruction packets to the instrumentdriver 130, the process of step 908. These packets indicate thepercentage of the surgeon-established maximum speed at which the motor206 should run. As long as controller 120 determines there is no need todeflect the cutting accessory 202, these instruction packets indicatethat the motor should run at 100% of the established maximum speed.

As long as these instruction packets are received, whenever instrumentdriver 130 receives an indication there has been depression of thetrigger 208, the driver outputs energization signals to cause the motor206 to run at the maximum speed. Instrument driver 130 takes this actioneven if the depression of the trigger is such that, if the system wasoperated in the below-discussed manual mode, the driver would outputenergization signals that would cause the motor 206 to run at a speedbelow the maximum speed.

In the version of the invention illustrated by FIG. 64, controller 120causes the speed of the motor 206 to be selectively attenuated as afunction of the extent to which bur head 204 is deflected away from thehome position, i.e., the control system 100 tracks deviation of theworking portion from the home position during the medical procedure.Here, controller 120 does not generate instructions to attenuate themotor speed as long as the computer determines there is no need todeflect the bur head 204 from the home position. In other words, theworking portion is capable of operating at the maximum cutting speedwhen the working portion is in the home position and the control system100 attenuates the cutting speed of the working portion when the workingportion deviates from the home position. Specifically, as discussedfurther below, when the working portion crosses a virtual boundary,e.g., work boundary 106 defined in control system 100, the workingportion deviates from the home position to deflect the working portionaway from the virtual boundary. Said differently, the working portiondeflects away from the work boundary 106 of the tissue to preventremoval of tissue beyond the work boundary 106.

The control system 100 attenuates the cutting speed of the workingportion based on this deviation. Speed control of the motor 206 is basedon several factors including 1) the maximum speed set by thepractitioner, 2) the depression of trigger 208 by the practitioner, 3)the percentage of total deflection, and 4) the shape of the speedprofile, i.e., FIG. 64. When it is necessary for the computer todetermine a deflected position for the bur head 204, controller 120determines the percentage of the deflection of the bur head 204. Thisdeflection is based on a proportional comparison of the necessarydiversion to the maximum possible diversion of the bur head 204. In oneversion of the invention, the maximum possible diversion is the distancefrom the home position to the outer range of the total possibledeflection of the cutting accessory 202. Along any one of the individualX-, Y- and Z-axes, this distance may be less than the actual possiblemaximum diversion of the cutting accessory 202 along that axis.

As long as the calculated necessary diversions of the bur head 204 arebelow a set percentage of the maximum possible deflection, controller120 continues to not generate any instructions to attenuate the motorspeed. Once the calculated deflection of the bur head 204 is above athreshold percentage of the maximum deflection, controller 120 starts toattenuate motor speed. In the example of FIG. 64, the thresholdpercentage is 40% of the maximum deflection. When the system 100 is inthis state, controller 120 transmits instruction packets to driver 130that indicate the motor 206 is to be driven at less than 100% of theestablished maximum speed. These instruction packets direct console 130to cause energization signals to be applied to the motor 206 that resultin the motor 206 running at a speed that is less than 100% of theuser-set speed for the motor 206. Controller 120 determines thepercentage of the user-set speed the motor 206 should operate at as afunction of the percentage of the calculated deflection of the bur head204 relative to the maximum possible deflection. In the speed profile ofFIG. 64, when the calculated deflection reaches 90% of the maximumpossible deflection, controller 120 instructs the console 130 to turnoff the motor 206. As the deflection increases from 40% to 90% of themaximum possible deflection, controller 120 sends instruction packets tothe console 130 indicating that the motor speed should be decreasedlinearly from the 100% of the user-set speed to the motor off state.

In some versions of the invention console 130 asserts signals to theinstrument motor 206 that results in the active braking, activedeceleration of the motor 206 to the attenuated speed. This braking isthe primary force that decelerates the cutting accessory 202. Asecondary force that decelerates the cutting accessory 202 is theresistance of the bur head 204 against the tissue being cut.

In one version of the invention, controller 120 sends instructionpackets to console 130 indicating the extent to which the motor speedshould be attenuated at a frequency of between 500 and 2,000 Hz. Theseinstruction packets are sent even when the bur head 204 is in positionin which it is not necessary to slow the speed of the motor 204.

The disclosed navigation system that determines the relative position ofthe instrument 200 to the working boundary 106 is exemplary, notlimiting. For example, some navigation systems have trackers thatreflect light. Still other navigation systems include trackers withsensors that monitor light or electromagnetic fields emitted by fixedsources.

Controller 120 determines the relative position of the bur head 204 tothe constraint boundary 111. In one version of the invention, instrumentcontroller 120 performs this evaluation at a frequency of 1000 Hz. Manynavigation systems do not provide navigation data indicating therelative position of the instrument 200 to the bone to which theinstrument is applied at this frequency. Controller 120 compensates forthe relative slow updating of data from the navigation system. Onemethod of performing this compensation is to first use the data from thenavigation system to determine the positions of the trackers. Thesepositions are determined for at a number of times in order to determineaveraged positions. Based on these averaged tracker positions, therelative position of the distal end of the cutting accessory 202 to theworking boundary is determined. These averaging processes make itpossible to generate averaged indications of the position of the cuttingaccessory 202 relative to the working boundary 106 at times between thetimes of actual tracker positions are measured.

Each time controller 120 makes the above evaluation, the evaluation ismade based on the assumption that the bur head 204 is in the homeposition. Thus, in this evaluation, the fact that the bur head 204 mayactually be in a deflected position is disregarded. Instrumentcontroller 120 determines, based on each of these evaluations, what, ifany, the appropriate deflected position is for the bur head 204. Thus,if, as a result of one these evaluations, it is determined that the burhead 204 has crossed the constraint boundary 111, controller 120 maydetermine that the deflected position for the bur head 204 is evenfurther spaced from the home position than the current deflectedposition. Alternatively, instrument controller 120 may determine that,owing to the current relative position of the bur head 204 to theconstraint boundary 111, the appropriate deflected position for the burhead 204 is closer to the home position than the current deflectedposition. At the end of either determination, controller 120 generatestarget positions for the rotors integral to motors 220, 222 and 224.These target positions are transmitted to the motor controllers 230,232, 234. If the new target positions are different from the previoustarget positions, motor controllers 230, 232, 234 apply energizationsignals to the motors 220, 222, and 224, respectively, in order to forcedisplacement of the bur head 204 to the newly-determined targetposition.

As mentioned above, once instrument controller 120 determines it isappropriate to reposition the bur head 204 in a deflected position thatis a defined distance away from the home position, the controller causesthe speed of the motor 206 to be attenuated. As a consequence the dropoff of motor speed, the pitch of the noises generated by the instrument200 changes. One reason is that the fall off in motor speed invariablyresults in a change of characteristics of the noise emitted by the motor206. Should the bur head 204 be pressed against the bone, the pitch ofthe noise generated as a consequence of this metal-against-bone contactalso changes. These changes in sound provide the practitioner feedbackthat the bur head 204 is approaching or at the working boundary 106.

The above aural feedback the practitioner receives from the motor 206 isthe reason in one embodiment system 100 is configured so that the usermay not attenuate the motor 206 from the initially set maximum speed. Ifthe practitioner is, during the procedure, allowed to reduce the speedof the motor 206, it may be difficult for the practitioner to aurallyperceive an attenuation in motor speed as a consequence of the cuttingaccessory 202 approaching or breaching the working boundary 106.

Another source of feedback to the practitioner is that, as a result ofthe slowing of the instrument the vibration of the instrument in thepractitioner's hand changes. As a result of this feedback, thepractitioner is placed on notice that, to avoid having the bur head 204remove tissue beyond the working boundary 106, it is necessary toreposition the bur head 204 and/or adjust the force applied to theinstrument to press the bur head 204 against the bone.

Another feedback source the practitioner has regarding the position ofthe bur head 204 relative to the working boundary 106 is the relativeposition of the cutting accessory 202 to the rest of the handpiece.Visually moderate to large displacement of the cutting accessory 202from the home position is readily apparent. The movement of the cuttingaccessory 202 to one of these displaced positions therefore serves as avisual cue to the practitioner that the bur head 204 is at orapproaching the working boundary 106.

There may be circumstances in which it appears that the position of theinstrument is not being reset sufficiently to avoid having the bur head204 remove tissue from beyond the working boundary 106. It should beunderstood that when the instrument is in this position, it is alreadyin the state in which the cutting accessory 202 is deflected from thehome position. In this state though, the diversion of the cuttingaccessory 202 is less than the maximum possible diversion. In this case,the further necessary diversion of the cutting accessory 202 wouldexceed the maximum allowed diversion. In the example depicted in FIG.64, the maximum allowed diversion is 90% of the total diversion. Ifcontroller 120 determines it is necessary to so reposition the bur head204 in order to avoid having the bur head 204 move beyond the workingboundary 106, the controller 120 sends an instructional packet toconsole 130 directing the console 130 to terminate the application ofenergization signals to the motor 206.

The stopping of the instrument motor 206 has two end effects. First, thestopping of the motor 206 prevents the bur head 204 from cutting tissuebeyond the working boundary 106. Secondly, the stopping of the motor 206provides the practitioner notice that, to avoid, cutting tissue outsideof the working boundary 106, it is necessary to reposition theinstrument 200. Repositioning of the instrument 200 away from theworking boundary 106 results in the continued application ofenergization signals to the motor 206.

After the bur head 204 is deflected, the practitioner continues toreposition the surgical instrument. As a consequence of thisrepositioning, controller 120 often determines that the instrument ispositioned so that, if the bur head 204 is in the home position, the burhead 204 will be spaced from the constraint boundary 111. When thiscondition occurs, controller 120 sends instruction packets to the motorcontrollers 230, 232 and 234, with target positions that indicate thatthe motor rotors should be in the home angular positions. The countvalues in these instruction packets are zero. In response to the receiptof these instruction packets, the motor controllers 230, 232 and 234selectively actuate motors 220, 222 and 224, respectively. The motors220, 222, and 224 are actuated to return carriage 302 and links 316 and416 back to their home positions. This displacement of the carriage 302and the links 316 and 416 results in a like return of the bur head 204to the home position.

System 100 can also control the position of the cutting accessory 202 inwhat is referred to as an “active” mode. In the active mode, controller120 does not deflect the cutting accessory 202 away from a constraintboundary 111. Instead, the controller 120 actively directs the cuttingaccessory 202 to a path along which tissue is to be removed. Forexample, the system may be operated in the active mode to cut a bore orother void space in the bone that is located along a specificlongitudinal axis.

To form a void space in the active mode, the longitudinal axis of thevoid space is initially defined and loaded into the controller 120. Anextension of this axis is plotted to extend out of the bone. Thepractitioner, holding the instrument so that the bur head 204 is justabove the location for the opening into the void space, brings theinstrument into approximate alignment with this axis. This task isperformed by reference to the image presented on the surgical navigationdisplay. This image includes a depiction of the axis along which thevoid space is to be formed.

Initially, the controller 120 determines if the distal end of thecutting accessory 202 is within a set space above the surface of thebone in which the opening is to be cut. In some applications of thisinvention, this distance is approximately 0.5 to 1.5 cm. Controller 120then determines if the cutting accessory 202 is within a given radius, asnapping radius of the location where the void is to be formed. Thisradius is typically less than the maximum deflection radius of thecutting accessory 202. If the instrument 200 is not so positioned, thecontroller 120 causes a message to be presented on the navigationdisplay that it is necessary for the practitioner to reposition theinstrument. If controller 120 determines that the cutting accessory 202is within the snapping radius, the computer deflects, snaps, the cuttingaccessory 202. Specifically, controller 120 instructs the motorcontrollers 230, 232, 234 to actuate the instrument motors 220, 222 and224, so that the distal end of the cutting accessory 202 is positionedimmediately above the location at which the void space is to be formed.During these steps of the process, controller 120 sends instructionpackets to console 130 that prevent the operation of the instrumentmotor 206.

The practitioner's continued movement of the instrument thus results inthe distal end of the cutting accessory 202 being pressed against thesurface of the tissue at the location in which the void is to be formed.Again, at this time, the practitioner is not able to actuate theinstrument motor 206. Also, images are presented on the navigationdisplay that indicate the relative location of the instrument to theaxis along which the void space is to be formed.

Once the instrument 200 is so positioned, the practitioner, based on theimages of the instrument relative to the target axis, orientates theinstrument. As a consequence of the initial orienting of the instrument,controller 120 returns cutting accessory 202 to the home position. Thepractitioner continues to orient the instrument. Specifically, based onthe images indicating the orientation of the cutting accessory 202relative to the target axis, continues to orient the accessory until itis in registration over this axis.

As a consequence of the monitoring of the information on the navigationscreen, the practitioner becomes aware of the fact that the cuttingaccessory 202 is aligned on the axis along which the void space is to beformed. Once the controller 120 determines that the instrument 120 is inthis state, the controller starts to send instruction packets to console130 indicating that the instrument motor 206 can be actuated. Thepractitioner at this time depresses trigger 208 to actuate motor 206.The cutting accessory 202 is therefore energized so as to cause theformation in the tissue of the intended void space at both the targetlocation and along the target axis.

Once the practitioner starts to form the void, controller 120appreciably restricts the practitioner's ability to apply the cuttingaccessory 202 off the target axis. For example, in some implementationsof the invention, as soon as the navigation system provides anyindication that the cutting accessory 202 is moving off axis, controller120 immediately instructs the console 130 to terminate the applicationof energization signals to the instrument motor 206. Controller 120takes this action without performing any deflection of the cuttingaccessory 202. This reduces the likelihood that, as the depth of thevoid space increases, the void space is formed along an axis that is offaxis with the target axis. In some implementations of this feature ofthe invention, the acceptable variation of the misalignment of thecutting accessory 202 with the target axis may vary inversely as thedepth of the void space being formed increases.

Controller 120 monitors the depth of the cut. In some versions of theinvention, when it is determined that that the depth of the void spaceis between 0.1 and 2.0 mm of the target depth, controller 120 starts todeflect the cutting accessory 202. This particular type of deflectionmay just be the rearward retraction of the cutting accessory 202. As thecarrier is deflected, controller 120 sends instruction packets toconsole 130 that causes for the slowing and then the stopping of motor206. These process steps thus cause the resultant void space to beformed to the target depth.

In an alternative use of system 100 in the active mode, the system 100displays prompts that direct the practitioner to position the handpieceso that bur head 204 is adjacent the surface of the tissue to beremoved. This distance is less than maximum distance the bur head 204can be deflected from the home position. Typically, this distance isless than 20 to 80% of the total distance which the bur head 204 can bedeflected.

Once the instrument 200 is so positioned, the instrument controller 120sends instructions to the motor controllers 230, 232 and 234 that resultin the diversion of the bur head 204 from the home position towards thetissue that is to be cut. The bur head 204 removes the tissue. Duringthis process, the instructions controller 120 generates instructionsregarding the displacement of the bur head 204, only result in thedisplacement of the bur head 204 towards the working boundary 106.Controller 120 does not send instructions that would result in therepositioning of the bur head 204 beyond the working boundary 106. Thus,in this process, the controller 120 sends the instructions that directthe bur head 204 to sculpt the bone into the desired shape.

In this process, the practitioner may move the instrument closer towardsthe bone being cut. In response to the controller 120 determining thatthe instrument is being so repositioned, the computer adjusts the extentto which the bur head 204 needs to be deflected to perform the desiredtissue removal. In this readjustment of the position of the bur head204, the bur head 204 may be reset to the home position. In situationswhere the instrument 200 is moved even closer to bone, controller 120may then determine it is necessary to start deflecting the bur head 204away the tissue being cut. Thus, an aspect of this active mode operationof the instrument may include the passive mode diversion of the bur head24 in order to avoid removing tissue beyond the working boundary.

The above described operation of the system 100 alternating between theactive and passive modes can be considered hybrid mode operation of thesystem 100. The operation may be useful to form surfaces of the bone.These surfaces include surfaces located inwardly from the exposed faceof the bone that define void spaces located within the bone.

The system 100 can also be operated in a manual override mode. In thismode the user overrides the ability of the motors 220, 222, 224 tore-position the bur head 204. In this mode the instrument 200 defaultsto the home position and essentially become a fixed, stiff, burringtool. Elements of controlling the rotational speed of the bur head 204could be maintained if desired (for example: cutting outside of theconstraint boundary 111 could still be disallowed). A complete overridewould allow the user to use the trigger 208 to vary the rotational speedof the bur head 204 (in the active and passive modes, the trigger 208 issimply an on/off safety feature). This would essentially make theinstrument 200 a conventional instrument because it would no longer beguided by the navigation unit 108.

It should be understood that when the instrument is operated in theabove-described modes, the self locking features of the nuts on the leadscrews prevent the unintended displacement, backdriving, of the bur head204 from the home position.

The passive and active modes can be thought of as the two ends of aspectrum of possible operating modes (for surface machining), butvariants are possible. For instance, the system 100 could operate in apassive mode with bur tip prediction. In this mode, the bur head 204starts accelerating away from the work boundary 106 prior to actuallyreaching the work boundary 106. To do this, estimates of futurepositions of the bur head 204 are needed. In addition to positions, thespeeds of both the target bone 102 and instrument 200 are outputted fromthe navigation unit 108 to the instrument controller 120 to predict thefuture positions of the bur head 204 relative to the bone 102 andinstrument 200 and react accordingly. This mode utilizes knowledge ofeach motor's performance specifications (akin to knowing a motor'sspeed-torque curve). This variant of the passive mode increases theinstrument's performance envelope (reactivity) and overall accuracy.

Another hybrid mode is adding a longer “sticking” time. In such a mode,the control system 100 is configured to control the actuators, e.g.,motors 220, 222, and 224, to actively position the working portion atthe boundary while the user moves the hand-held portion relative to theboundary such that the working portion is substantially maintained atthe boundary independent of the movement of the hand-held portion. Inessence, the bur head 204 acts like a magnet to a boundary only afterthe bur head 204 has begun “riding” on that boundary. This isaccomplished by allowing the bur head 204 to travel beyond the “Home”position while the bur head 204 is pulled away from the boundary. Thisfeature may be adjustable as a user preference.

Still another hybrid mode of operation is semi-autonomous cutting. Inthis mode, the control system 100 is configured to control the actuatorsto move the working portion relative to the hand-held portion such thatthe working portion autonomously follows a path defined in the controlsystem 100 to remove the target volume of the material while the usersubstantially maintains the hand-held portion in a gross positionrelative to the target volume during the medical procedure. Here, theuser grossly positions the bur head 204 and then holds the instrument200 in a region of interest. The bur head 204 is then guided and movedbased on signals from the instrument controller 120 to the controllers230, 232, 234 to cut out the target volume of material 104 defined bythe work boundary 106. The instrument 200, much like a CNC mill, wouldthen execute a semi-autonomous run by following a prescribed pathcalculated by the instrument controller 120 or the user (or a pathgenerated on-the-fly). The instrument path's coverage would be limitedby the available range of motion (and the user's ability to hold theinstrument 200 still).

Another hybrid mode of operation involves dithering in which the cuttingaccessory 202 is moved in controlled pattern. This pattern may be onethat results in the bur head shaping the bone 102 so as to result thefinished surface having a specific degree of smoothness. In a ditheringoperation, the cutting accessory 202 may be moved from the home positionso as to cause the bur head 204 to: move in an orbital pattern; move ina figure-eight pattern; and/or oscillate along a defined arc. Thisdithering is performed parallel to the surface of the local boundary.

VI. Applications

Referring to FIG. 65, one possible application for the system is forbone sculpting as described above. In essence, the removed bone providesa “negative” cavity 1006 for an implant (e.g., knee implant). Theinstrument 200 could also cut complex 3-D shapes (i.e. mirror symmetricfeatures). Likewise, the instrument 200 could be used toshave/smooth-out jagged bone and deformities.

Referring to FIG. 66, the system 100 could be used for tunneling intobone, other tissue, or other materials. The instrument 200 can beconfigured to bore a straight hole 1008 that equals (or is slightlylarger) than a diameter of the bur head 204. As FIG. 66 shows invertedcone constraint geometry 1010 could be defined for accessing variousparts of the body (e.g., spine).

Referring to FIG. 67A-67C, use of the system 100 for targeting/alignmentis shown. This allows a user (e.g., surgeon) to quickly locate apre-planned or predefined location of a hole 1012 by “snapping” the tipof a drill bit 1014 to the hole's centerline (e.g., pre-drilling forpedicle screws). Once located, the display 1402 could then be used toproperly align the axis of the drill bit 1014 (or other cuttingaccessory) to the axis of the desired hole 1012. With reference toscreen shot of the display 1402 shown in FIG. 68, the display shows dots1016 that indicate the alignment is off-axis 1018 and needs to be moved.The instrument 200 corrects for deviations in alignment as drilling isunderway by changing the pitch, yaw, or translation along the axis Z ofthe drill bit 1014.

Referring to FIG. 69, the instrument 200 may be used for cutting,ablating, or other surgical procedure near soft tissues and nerves 1020with the ability to avoid these delicate areas. In this application,pre-op imaging and pre-planning to create constraint boundaries to avoidthese sensitive areas. In some embodiments, the instrument 200 can becombined with a nerve monitor to prevent damaging nerves. This mappingcan be performed during the procedure as the need arises.

Referring to FIG. 70, the instrument 200 can be depth controlled. Thisallows the user to cut or drill to a specified depth (e.g., pediclescrews). The user, however, prevented from cutting too deeply orbreaking thru other side of bone (e.g., bi-cortical screw). In thisapplication, the work boundary is the depth surface of the bore.

Referring to FIG. 71, the instrument 200 can also be used for customimplant shaping. In this application, a bur or other shaping tool cancut non-bone objects 1022 to a specified shape (e.g., plastic implants).The system could also be configured to modify objects to conform andmatch surfaces previously created while sculpting or manually cuttingwith the instrument 200.

The system 100 and instrument 200 described herein are merely exemplaryof the present invention. The invention could be utilized on severaltissue types, including hard and soft tissues, for materials likeplastic and metal, and for many different procedures, including, but notlimited to cutting, ablating, drilling, general collision avoidance, andthe like.

VII. Alternative Embodiments

The foregoing is directed to one specific version of system. Alternativeversions of the system of this invention are possible. For example,instrument 200 can have a mechanism that vibrates (like an eccentricmotor) while near a boundary, on boundary, or after exceeding a certainamount of deflection. This provides the user with further feedback thatthe distal end tip of the cutting accessory is approaching the boundary.Lights (e.g., LEDs) could be provided on the instrument 200, such as thehandle 502 to provide visual indication of the proximity of the cuttingaccessory to the working boundary. For instance, a green signal=good,yellow=on boundary, red=problem/stop.

Features may be provided on the instrument 200 to show the extent towhich the bur head 204 is deflected from its home position. Thesefeatures may be incorporated in the display 1402 on the instrument 200(see FIG. 1 and FIG. 68). The display 1402 is preferably mounted to thehandle 502 to remain fixed relative to the handle 502 during use. Inalternative embodiments, the display 1402 is attached to the upperassembly 300 to move with the upper assembly 300. A driver (not shown)for the display 1402 is installed in the instrument controller 120.

Surgical instrument 200 of this invention may be used with navigationsystems other than the described system. For example, the instrument canbe used with an image-less navigation system.

For bone sculpting applications, the display 1402 would give the statusof the current amount of deflection of the cutting accessory 202/burhead 204 or whether it is in the “Home” position. ForTargeting/Alignment applications, the display 1402 would direct the userto align a cutting accessory's axis with a target axis. During thesemi-autonomous cutting mode, the display 1402 could give visualinstructions to inform the user where best to grossly position the burhead 204 or instrument 200. In addition, the display 1402 could displaynavigation information (i.e. blocked LEDs for tracking purposes,percentage of cut completed, where additional material needs to beremoved, etc.).

Data connection 1002 may be an IEEE 1394 interface, which is a serialbus interface standard for high-speed communications and isochronousreal-time data transfer between the instrument controller 120 and thedisplay 1402. Data connection 1002 could use a company specificprotocol.

Alternative assemblies may be provided for moving the cutting accessoryto/from the home position. For example, mechanical assemblies thattransfer power from the motors may include assemblies other than nutsdisposed on lead screws. One such assembly could have a drive plate thatis attached to the motor. The plate includes a pin that engages a linkconnected to the cutting accessory in order to displace the cuttingaccessory. Also, in some versions of the invention, belt drives may beemployed to displace the cutting accessory. Still in another version ofthe invention the actuation of a motor may displace a rack. The rack islinked to the cutting accessory to displace the cutting accessory.

In another alternative version of the invention, the gimbal to which thecutting accessory is mounted is itself pivotally mounted to the body ofthe instrument. Thus the gimbal still provides the X- and Y-axesdeflection of the cutting accessory. In these versions of the invention,the mechanism that holds the cutting accessory to the gimbal is moveablymounted to the gimbal. For example either the motor and couplingassembly or just the coupling assembly may be mounted to the gimbal soas to be able to move proximally or distally. In these versions of theinvention, the motor that moves the cutting accessory distally andproximally may itself also be mounted to the gimbal to pivot with thegimbal. This displacement of the cutting accessory is, it should beappreciated, the displacement of the cutting accessory along axis Z.

Similarly, there is no requirement that, in all versions of theinvention, mechanical energy be the source of power that positions thecutting accessory. For example the cutting accessory may beelectromagnetically selectively displaced to/from the home position. Inone version of this embodiment of the invention, instrument 200 mayinclude solenoids. These solenoids are selectively actuated toretract/extend pins that are attached to the cutting accessory. The pinsare selectively extended/retracted to cause the displacement of thecutting accessory to/from the home position. Alternatively, there may beother coils mounted internal to the instrument. These coils generatelocalized magnetic fields. The coils in each set of coils selectivelyattract or repel a set of magnets on the cutting accessory. The movementof the magnets results in the movement of the cutting accessory. In thisversion of the invention, the energization of a particular set of coilsmay selectively reply/attract a set of magnets that results in thesimultaneous displacement of the cutting accessory on two or three axes.

Assemblies other than the fine pitched lead screws may function as theself locking feature of the instrument that blocks unintended backmovement of the cutting accessory when the accessory is exposed toresistance. The exact structure of the self locking assembly is afunction of the structure of the actuators that displace the cuttingaccessory. For example, if electromagnetic actuators are employed, theactuators serve as the self locking mechanism. Specifically, currentsare applied to the coils to prevent resistive forces applied to thecutting accessory from preventing the unintended displacement of thecutting accessory. In some versions springs may also apply forces thatinhibit the unintended movement of the cutting accessory. A cam assemblymay also be used to lock the cutting accessory from unintended movement.

Instrument 200 may include components other than the describedHall-effect sensors internal to the motors to determine and control theposition of the cutting accessory 202. For example in some versions ofthe invention, absolute rotary position encoders or absolute angularposition encoders may be used to monitor the rotational positions of thecomponents that displace the cutting accessory. For monitoring sometypes of motion, for example, motion of the carriage along the axis Z,absolute linear position encoders may be incorporated into theinstrument of this invention. In these versions of the invention, theremay not be a need to provide supplemental position encoders tofacilitate the zero state or home centering of the cutting accessory.

There is no requirement that in all versions of the invention the motoror other component that provides energy to the cutting accessory 202 berigidly connected to the cutting accessory 202. Thus in some versions ofthe invention, the energy output component may be flexibly linked to thecutting accessory 202. If, for example, the cutting accessory 202 is amechanically driven device, some type of drive cable or flexible jointmay transfer the motive power to the cutting accessory 202. For examplethe motor could be fixedly secured to the moveable carrier 305 while thecutting accessory 202 is pivotally connected to the carrier 305. Anadvantage of this structure is that it reduces the mass of the componentof the instrument 200 that needs to be moved towards/away from the homeposition.

In some versions of the invention, instrument 200 may be designed sothat the extent to which the cutting accessory 202 may be displaced uponeach of the X-, Y- and Z-axes is not equal to each other.

Also, there may be variations in the processes used to position thecutting accessory 202 in the home position. For example, typically, ifthe cutting accessory 202 is to be displaced along the axis Z, theaccessory 202 is more often than not, moved rearward, proximally.Controller 120 therefore establishes a Z-axis home position for thecarriage 302 that is typically forward of, distal to, the home positioninitially established during the homing process. This offsetting of thehome position increases the extent to which, during the procedure, thecutting accessory 202 can be retracted proximally.

One means of so resetting the home position of the carrier 302 is toinitially actuate the motor 224 so as to cause the carrier 302 to moveto home position using the above-described homing process. Controller120 then adds an offset count to the previously calculated targetposition count upon which the carrier 302 was moved to the displacedhome position. This offset count is based on data previously stored inthe controller 120. This offset target position count is then forwardedto the motor controller 234. Controller 234 actuates the motor 224 tocause the carrier 302 to move distally. The carrier 302 is moved untilthe cumulative count from the motor equals the offset target positioncount. Once the carrier 302 is so repositioned in the offset homeposition, the controller 120 zeros out the cumulative count.

When the Z-axis home position of the cutting accessory 202 is so offset,the range of motion of the accessory tip or bur head 204 along the axisZ does not equal the range of motion of the tip or bur head 204 alongthe X- and Y-axes. Thus, in these implementations of the invention, theboundary of the spaced volume through which the accessory tip or burhead 204 moves when displaced to its maximum deflected positions is notspherical.

Likewise, it should be understood that in other versions of theinvention, the full range of deflection of the cutting accessory tip orbur head 204 in the X- and Y-axes may not be equal.

The extent to which the speed of the instrument motor 206 is attenuatedmay also vary from what was described with respect to FIG. 64. Forexample, in some versions of the invention as soon as there is anydeflection of the cutting accessory 202 from the home position, thecontroller 120 causes some attenuation of the motor speed. This providesthe practitioner some immediate aural and tactile feedback that the burhead 204 is at the working boundary 106. The level of this speedattenuation remains constant as long as the deflection is within a setpercentage of the maximum cumulative deflection. Once the deflectionexceeds this threshold percentage, the controller 120 assertsinstruction packets to the console 130 that serve to increase the extentto which the motor speed is attenuated. This provides a second set ofaural and tactile feedback signals to the practitioner that it may beappropriate to further adjust the position of and force applied to thecutting accessory 202.

Further in some versions of the invention, the controller 120 may causethe speed of the instrument motor 206 to be attenuated as a function ofthe proximity of the accessory tip or bur head 204 to the workingboundary 106. Specifically, there may be instrument packets sent to theconsole 130 that result in a first level of speed attenuation when it isdetermined that the accessory tip or bur head 204 is a first distancefrom the working boundary 106. Once the accessory tip or bur head 204intersects or crosses the working boundary 106, the controller 120causes the motor speed to be attenuated to a second level. Then, as theextent to which the bur head 204 is diverted from the home positionincreases beyond a threshold level, the controller 120 increases theattenuation of the motor speed. This stepped attenuation of motor speedprovides the practitioner with a stepped indication of the proximity ofthe accessory tip or bur head 204 to the working boundary 106.

Also, the processes by which the controller 120 determines the relativeposition of the distal end tip of the cutting accessory 202 relative tothe working boundary 106 may differ from what has been described.Ideally, the navigation unit 108 should be able to provide data fromwhich this position can be determined at a frequency equal to thefrequency with which the computer recalculates the extent to which thecutting accessory 202 is to be moved from the home position. Inactuality, navigation systems are typically not able to performmeasurements at these frequencies. One potential solution is to have thecontroller 120 use the last few frames of data from the navigation unit108 to determine the velocity of the direction of the instrument 200towards/away from the bone. Based on this determination, the controller120 generates extrapolated estimations of the relative location of theinstrument 200 to the bone after the last true position informationreceived from the navigation unit 108. Based on these predictions ofinstrument position, the controller 120 determines whether or not andthe extent to which cutting accessory 202 should be diverted from thehome position.

Still other means of providing measured or arcuate estimates of therelative position and orientation of the distal end of the cuttingaccessory 202 relative to the working boundary 106 are associated withfeatures of the navigation unit 108 that are not within the scope of thecurrent invention.

Likewise, depending on the processing speed and/or the ability totransmit data to/from the controller 120, it may not always be necessaryto determine the relative position of the cutting accessory 202 based onthe assumption that the accessory 202 is in the home position. It iswithin the scope of this invention that this determination be made basednot only on the relative position of the trackers 114, 116. Thisadditional data includes data defining the extent to which the distalend of the cutting accessory 202 is diverted from the home position.

Likewise there is no requirement that all components be in all versionsof the invention. For example, it may be that in some versions of thesystem 100 that a single set of sensors provide the signals used to bothinitially center or home the cutting accessory 202 and then to monitorthe extent to which the cutting accessory 202 is displaced from the homeposition.

Also, the degree of required alignment should be understood to be afunction of the type of cutting accessory 202 fitted to the instrument200. For example, when forming a bore hole in the active mode, it isoften necessary to more precisely position the cutting accessory 202when the accessory 202 is a drill bit as opposed to a bur head 204.

In alternative embodiments, the controllers 230, 232 and 234 thatregulate the actuators that set the position of the cutting accessory202 are mounted in the control unit 120. This eliminates the need toprovide the instrument 200 with a structure like shell 670.

It should likewise be appreciated that precision of the operation ofinstrument 200 can be enhanced by increasing the frequency with whichthe accessory to boundary determination and subsequent instrumentcontrol cycles are preformed. For example, it may be desirable toprovide the instrument controller 120 with hardware and software capableof executing these cycles at a frequencies of 2 kHz and higher, 4 kHzand higher and 8 kHz and higher.

In some embodiments the tracking devices114, 116 attached to theinstrument 200 and the anatomy may be non-optically based trackers suchas tracking devices that transmit or receive electromagnetic waves,ultrasonic waves, RF signals, or other tracking devices known to thosehaving ordinary skill in the art.

VIII. Pencil Grip Embodiment

In addition to the alternative embodiments described in the sectionabove, FIGS. 72-111 show another embodiment of the surgical instrument,hereinafter numbered 1200, that has a pencil grip configuration.Surgical instrument 1200 can be used in the tracking and control system100 shown in FIG. 1 and described above. As set forth above, thetracking and control system 100 tracks the positions and orientations ofthe target volume 104 and the surgical instrument 1200 to keep the tipor bur head 204 of the cutting accessory 202 at the target volume 104.Surgical instrument 1200 can be used in the same applications assurgical instrument 200 discussed above. Surgical instrument 1200typically includes a cord 1203 for connection to the tracking andcontrol system 100, and specifically to the instrument controller 120.

With reference to FIGS. 72-74, the surgical instrument 1200 includes adistal assembly 1202, also referred to as a drive assembly 1202, and aproximal assembly 1204, also referred to as the hand-held portion 1204.The hand-held portion 1204 is manually supported and moved by a user.The user operates the instrument 1200 by grasping and supportinghand-held portion 1204 and the instrument 1200 is unsupported by othermechanical arms, frames, etc. As set forth with the embodimentsdescribed above, the tracking device 114 is attached to the hand-heldportion 1204 for tracking the instrument 1200.

The working portion, e.g., the cutting accessory 202, is movably coupledto the hand-held portion 1204. As set forth in greater detail below, thedistal assembly 1202 releasably holds the working portion, e.g., thecutting accessory 202, drives the working portion to perform themedical/surgical task on the tissue of the patient, and moves theworking portion in the axis Z, as identified in FIGS. 72 and 73, toprevent the distal tip or bur head 204 of the accessory 202 fromcolliding with or breaching the work boundary 106 of the target volume104 to which the cutting accessory 202 is being applied.

The proximal assembly 1204 engages the distal assembly 1202 and movesthe distal assembly 1202 to adjust the pitch and yaw of the cuttingaccessory 202 to prevent the distal tip or bur head 204 of the accessory202 from colliding with or breaching the work boundary 106 of the targetvolume 104. As set forth above, “pitch” is the up-down angularorientation (i.e., the X-axis shown in the Figures) of the longitudinalaxis A of the distal assembly 1202 and the cutting accessory 202relative to a horizontal plane through the center of a gimbal bushing1256 and “yaw” is the right-left angular orientation (i.e., the Y-axisshown in the Figures) of the longitudinal axis A of the distal assembly1202 and the cutting accessory 202 relative to a vertical plane throughthe center of the gimbal bushing 1256. FIGS. 75A-C, for example, showthree different positions of adjustment in the pitch of the distalassembly 1202 relative to the proximal assembly 1204. The range ofmotion of the tip 204 of the cutting accessory 202 relative to thedistal assembly 1202 as defined by the control system 100 is shown as acircle C in FIGS. 75A-C and 85-87. Various views of the distal assembly1202, or portions thereof, are shown in FIGS. 74-106. With reference toFIGS. 75A-C, the proximal assembly 1204 includes an outer casing 1206and the distal assembly 1202 includes a casing 1208 that remainsrotationally fixed about the longitudal axis A relative to the outercasing 1206 of the proximal assembly 1204. Proximal assembly 1204engages the distal assembly 1202 and adjusts the pitch and yaw of thedistal assembly 1202 relative to the proximal assembly 1204, as setforth further below.

With reference to FIGS. 75A-C, a nose tube 1218 extends from the casing1208 and supports the cutting accessory 202. The nose tube 1218 definesa nose tube bore 1220 (as best shown in FIGS. 76 and 80). A colletassembly 1211 (shown in isolation in FIGS. 81-84) is rotatably disposedin the nose tube bore 1220 for releasably engaging the cutting accessory202 in the nose tube bore 1220, as set forth further below.

A drive mechanism 1201 is coupled to the working portion for rotatingthe working portion about the longitudal axis A as indicated by arc R.The drive mechanism 1201 includes a drive motor 1212, also referred toas an accessory motor 1212, disposed in the casing 1208 for driving thecollet assembly 1211 and the cutting accessory 202, e.g., for rotatingthe cutting accessory 202.

As set forth further below, the drive assembly 1202 and the cuttingaccessory 202 move relative to the hand-held portion 1204 in a pluralityof degrees of freedom. A plurality of actuators, e.g., lead screw motor1240, yaw motor 1302, and pitch motor 1304, are operatively coupled tothe working portion for moving the working portion in a plurality ofdegrees of freedom relative to the hand-held portion 1204.

The drive mechanism 1201 moves in at least one degree of freedomrelative to the hand-held portion 1204 and, more specifically, the drivemotor 1212 moves in at least two degrees of freedom relative to thehand-held portion 1204. At least one of the actuators, and morespecifically, the yaw motor 1302 and the pitch motor 1304, move thedrive mechanism 1201 and the drive motor 1212 in pitch and yaw relativeto the hand-held portion 1204. Specifically, the casing 1208 is movableby at least one of the actuators, e.g., the yaw motor 1302 and the pitchmotor 1304 in pitch and yaw relative to the hand-held portion 1204. Thedrive mechanism 1201 and the drive motor 1212 are fixed along thelongitudal axis A relative to the hand-held portion 1204. In thisembodiment, the longitudal axis A moves in pitch and yaw relative to thehand-held portion 1204.

As best shown in FIGS. 75A-C and 85-87, the plurality of actuators,e.g., lead screw motor 1240, yaw motor 1302, and pitch motor 1304, arecapable of moving the working portion relative to the hand-held portion1204 in at least three degrees of freedom including pitch, yaw, andtranslation along the longitudal axis A. In an embodiment where theworking portion, i.e., the cutting accessory 202, comprises a bur head204, the drive motor 1212 moves in four degrees of freedom relative tothe hand-held portion 1204, i.e., the drive motor 1212 rotates the burhead 204.

The drive assembly 1202 supports the working portion and one of theactuators and is movable by at least another of the actuators.Specifically the drive assembly 1202, and more specifically, the casing1208, supports the lead screw motor 1240, also referred to as axialmotor 1240, and the drive motor 1212. The lead screw motor 1240translates the working portion along the longitudal axis A. The driveassembly 1202 is movable by the yaw motor 1302 and the pitch motor 1304.The yaw motor 1302 and pitch motor 1304 move the drive motor 1212, theworking portion, and the lead screw motor 1240 in pitch and yaw relativeto the hand-held portion 1204.

The drive motor 1212 can be controlled by instrument driver 130 in thesame manner as motor 206 is controlled in the prior describedembodiments. A shaft 1210, as discussed further below, is disposed inthe casing 1208 and extends from the drive motor 1212 to the colletassembly 1211 for transmitting rotation from the drive motor 1212 to thecollet assembly 1211 for driving the cutting accessory 202.

The drive motor 1212 includes a rotor 1214, as shown for example in FIG.84, that is rotatably coupled to the casing 1208 to drive the cuttingaccessory 202. The rotor 1214 can include at least one bearing 1213engaging the casing 1208 to rotatably couple the rotor 1214 to thecasing 1208 and allow rotation of the rotor 1214 relative to the casing1208.

The rotor 1214 includes a keyed bore 1215. The shaft 1210, which isshown for example in FIG. 84, includes a first end 1217 configured toengage the keyed bore 1215 of the rotor 1214 such that rotation of therotor 1214 is transmitted to the shaft 1210. The cross-sectional shapeof the keyed bore 1215 and the first end 1217 are double-D shaped asshown in FIG. 84 but, alternatively, can be any suitable shape withoutdeparting from the nature of the present invention.

The collet assembly 1211 rotatably couples the drive shaft 1210 to thecutting accessory 202 so that the cutting accessory 202 rotates indirection R about the the longitudal axis A upon rotation of the driveshaft 1210. The collet assembly 1211, which is shown in isolation inFIGS. 81-84, is rotatably coupled to the nose tube 1218 in the nose tubebore 1220. With reference to FIG. 76, a stack-up 1285 of variouscomponents is disposed in the nose tube bore 1220 between the colletassembly 1211 and a lip 1281. A ring 1283, as best shown in FIG. 76, isfixed in the nose tube bore 1220, typically by press fit, adjacent thecollet assembly 1211 to retain the collet assembly 1211 and the stack-up1285 in the nose tube bore 1220.

The collet assembly 1211 can include at least one bearing 1219 (e.g.,shown in FIG. 76) engaging the nose tube 1218 to rotatably couple thecollet assembly 1211 to the nose tube 1218 and allow rotation of thecollet assembly 1211 relative to the nose tube 1208.

The collet assembly 1211 includes a keyed end 1221 and the shaft 1210includes a second end 1223 configured to engage the keyed end 1221 suchthat rotation of the shaft 1210 is transmitted to the collet assembly1211. The second end 1223 and the keyed end 1221 are moveable relativeto each other. Under normal operating conditions, the collet assembly1211 and the shaft 1210 move together as a unit and, when the colletassembly 1211 is moved to lock and unlock the cutting accessory 202, asset forth further below, the keyed end 1221 and the second end 1223 ofthe shaft 1210 slide relative to each other. The cross-sectional shapeof the keyed end 1221 and the second end 1223 of the shaft 1210 aredouble-D shaped as shown in FIG. 84 but, alternatively can be anysuitable shape without departing from the nature of the presentinvention.

With reference to FIG. 76, the nose tube 1218 supports the workingportion, e.g., cutting accessory 202, and is movable relative to thecasing 1208 in translation in the Z direction along the longitudal axisA, i.e., the nose tube 1218, which is typically cylindrical, adjusts theposition of the cutting accessory 202 along the longitudal axis A.

With reference to FIG. 85-89, during normal operation, the nose tube1218 is axially fixed relative to the shaft 1210 along the longitudalaxis A. As such, as the nose tube 1218 moves axially along thelongitudal axis A , the nose tube 1218 moves the shaft 1210 along thelongitudal axis A , as shown in FIGS. 85-87. When the collet assembly1221 is moved to lock and unlock the cutting accessory 202, the nosetube 1218 and the shaft 1210 move relative to each other, as shown inFIGS. 88 and 89 and as set forth further below.

With reference to FIGS. 78 and 79, nose tube bore 1220 rotatablyreceives the shaft 1210 and the cutting accessory 202. As best shown inFIG. 76, bearings 1222 are disposed in the nose tube bore 1220 forrotatably supporting the cutting accessory 202 in the nose tube bore1220.

With reference to FIGS. 85-87, the casing 1208 telescopically receivesthe nose tube 1218. As best shown in FIG. 90, the casing 1208 defineschannels 1224. As best shown in FIGS. 79 and 80, the nose tube 1218includes a flange 1226 including protrusions 1228 engaging the channels1224. Channels 1224 are circumferentially spaced from one another aboutthe casing 1208. The protrusions 1228 are circumferentially spaced fromone another about the nose tube 1218 to mate with the channels 1224.Channels 1224 extend parallel to the longitudal axis A and are sized andshaped to restrain the protrusions 1228 to movement along the longitudalaxis A. It is appreciated that the protrusions 1228 and channels 1224can be defined on either of the casing 1208 and the nose tube 1218, andthe casing 1208 and the nose tube 1218 can include any number ofcorresponding protrusions 1228 and channels 1224 without departing fromthe nature of the present invention. The casing 1208 can, for example,include a bushing 1265 that is fixed to the rest of the casing 1208 anddefines the channels 1224. The bushing 1265 is typically formed from adifferent type of material than the casing 1208. The bushing 1265 istypically formed of a material that provides a low-friction interfacewith the nose tube 1218 and is typically formed of a non-magneticmaterial to allow for position sensing.

As best shown in FIGS. 85-89 and 91-92, distal assembly 1202 includes alead screw 1230 rotatably mounted in the casing 1208. The lead screw1230 is typically cylindrical. Bearings 1232 are disposed in the casing1208 between the casing 1208 and the lead screw 1230.

With reference to FIGS. 85-89, the lead screw 1230 threadably engagesthe nose tube 1218. The nose tube 1218 telescopically extends from thelead screw 1230 along the longitudal axis A and is telescopicallyadjustable along the longitudal axis A relative to the lead screw 1230.Specifically, lead screw 1230 defines a lead screw bore 1234 andinterior threads 1236 in the lead screw bore 1234. Nose tube 1218defines exterior threads 1238. Lead screw 1230 telescopically receivesthe nose tube 1218 in the lead screw bore 1234. The exterior threads1238 of the nose tube 1218 threadedly engage the interior threads 1236in the lead screw bore 1234. The interior threads 1236 and the exteriorthreads 1238 have a fine pitch and lead angle to prevent back driving,i.e., to encourage self-locking.

As set forth above, the actuators include the lead screw motor 1240. Thelead screw motor 1240 includes a hollow rotor 1287, as identified inFIGS. 75A-C and 77, that rotatably receives the drive shaft 1210 thereinsuch that the drive shaft 1210 rotates within the hollow rotor 1287 andrelative to the hollow rotor 1287 so as to rotatably drive the workingportion.

The nose tube 1218 is threadedly coupled to the hollow rotor 1287.Specifically, lead screw motor 1240, as best shown in FIGS. 85-87, isengaged with the lead screw 1230 to rotate the lead screw 1230 and thenose tube 1218 is threadedly engaged with the lead screw 1230.

The nose tube 1218 is rotationally constrained in the casing 1208 suchthat the rotation of the hollow rotor 1287 telescopes the nose tube 1218relative to the casing 1208. In other words, since the engagement of thecorresponding protrusions 1228 and channels 1224 prevents rotation ofthe nose tube 1218 relative to the casing 1208 and allows translation ofthe nose tube 1218 relative to the casing 1208 along the longitudal axisA, the nose tube 1218 remains rotationally fixed relative to the casing1208 as the lead screw motor 1240 rotates the interior threads 1236 ofthe lead screw 1230 relative to the exterior threads 1238 of the nosetube 1218. This relative rotation of the interior threads 1236 and theexterior threads 1238 moves the nose tube 1218 along the longitudal axisA relative to the casing 1208. The protrusions 1228 slide in thechannels 1224, respectively, as the nose tube 1218 moves along thelongitudal axis A. As a result, the cutting accessory 202, which iscarried by the nose tube 1218 during operation, is translated along theaxis Z in response to rotation of the lead screw 1230.

FIGS. 85-87, for example, show the nose tube 1218 moved to differentlocations relative to the casing 1208 along the longitudal axis A.Specifically, in FIG. 85 the nose tube 1218 is nearly fully extended andin FIG. 87 the nose tube 1218 is nearly fully retracted. FIG. 86 shows aposition between those shown in FIGS. 85 and 87. Specifically, FIG. 86shows the nose tube 1218 in a “home” position. When the nose tube 1218moves relative to the casing 1208, the collet assembly 1211, the cuttingaccessory 202, and all other components housed in the nose tube 1218move with the nose tube 1218.

As shown in FIGS. 85-87, the keyed bore 1215 telescopically receives theshaft 1210. The shaft 1210 slides along the keyed bore 1215 as the shaft1210 is moved into and out of the keyed bore 1215 as the nose tube 1218is extended and retracted along the longitudal axis A. As set forthabove, the first end 1217 of the shaft 1210 is configured to engage thekeyed bore 1215such that rotation is transmitted from the rotor 1214 tothe shaft 1210. As also set forth above, the second end 1223 isrotationally locked to the keyed end 1221 of the collet assembly 1211.As such, when the nose tube 1218 is retracted or extended, the shaft1210 slides in the keyed bore 1215 and transmits rotation to the colletassembly 1211 regardless of the position of the shaft 1210 in the keyedbore 1215.

With continued reference to FIGS. 85-87, bearing 1243 rotatably supportsthe shaft 1210 in the keyed bore 1215. Bearing 1243 is disposed betweena rotor of lead screw motor 1240 and shaft 1210. Rotor of drive motor1212 rotates concentrically within lead screw motor 1240, while rotor oflead screw motor 1240 rotates about rotor of drive motor 1212. Shaft1210 is longitudinally slideable relative to bearing 1243 duringretraction and extension of the nose tube 1218.

Bearing 1245 rotatably supports the shaft 1210 in the nose tube 1218.Shaft 1210 is longitudinally slideable relative to bearing 1245 when thecollet assembly 1221 is moved to lock and unlock the cutting accessory202.

With reference to FIGS. 76 and 90, the flange 1226 can define a cavity1242 for receiving a position identifier such as magnet 1255. In such anembodiment, the casing 1208 or the bushing 1265 supports one or moreposition sensors, e.g., magnetic sensors (not shown), such as aHall-effect sensor, that measures the proximity of the magnet 1255 totrack the location of the nose tube 1218 along the longitudal axis A.The position sensor communicates with the control system 100.

As set forth above, the collet assembly 1211 releasably engages thecutting accessory 202. The collet assembly 1211 is configured to releasethe cutting accessory 202 in response to actuation of the lead screwmotor 1240 beyond a predefined limit of actuation. The collet assembly1211 engages the cutting accessory 202 to transmit movement, e.g.,torque, from the shaft 1210 to the cutting accessory 202. Specifically,the collet assembly 1211 rotationally fixes the cutting accessory 202 tothe shaft 1210. The collet assembly 1211, for example, could be of thetype shown in U.S. Pat. No. 5,888,200 to Walen, which is herebyincorporated by reference, or the type shown in U.S. Pat. No. 6,562,055to Walen, which is hereby incorporated by reference.

With reference to FIGS. 81-84, the collet assembly 1211 includes anouter sleeve 1225 and an inner member 1227 telescopically received inthe outer sleeve 1225. A clamping member 1267, i.e., a collet, as shownin FIG. 83, is sandwiched between the inner member 1227 and the outersleeve 1225. As set forth further below, the inner member 1227selectively biases the clamping member 1267 into engagement with thecutting accessory 202.

The clamping member 1267 includes a ring 1269 and at least one arm 1229extending from the ring 1269. FIG. 85 shows two arms 1229. It should beappreciated that the clamping member 1267 can include any number of arms1229 without departing from the nature of the present invention.

With reference to FIGS. 81 and 82, the inner member 1227 defines a bore1231 for receiving the cutting accessory 202. The inner member 1227defines at least one opening 1233, also shown in FIG. 84, incommunication with the bore 1231. Each arm 1229 includes a foot 1235that can extend through the opening 1233 and into the bore 1231 toengage the cutting accessory 202, as set forth further below.

The inner member 1227 is slideable longitudinally relative to the outersleeve 1225 and the arms 1229 between a locked position (shown in FIG.88) and an unlocked position (shown in FIG. 89). Specifically, in thelocked position, the outer sleeve 1225 provides a retention force on thearms 1229 to retain the feet 1235 in the opening 1233. In the unlockedposition, the outer sleeve 1225 is moved relative to the arms 1229 toeliminate the retention force and the feet 1235 are free to move out ofthe opening 1233. Specifically, when the outer sleeve 1225 is in theunlocked position, the feet 1235 naturally remain in the opening 1233,however, the arms 1229 are free to bend allowing the feet 1235 to moveout of the opening 1233. As such, when the cutting accessory 202 isinserted into the bore 1231, the cutting accessory 202 moves the feet1235 outwardly.

The collet assembly 1211 includes a pin 1251 that abuts the shaft 1210,as best shown in FIG. 88. A spring 1279 pre-loads the shaft 1210 intoengagement with the pin 1251. In particular, a collar 1299 is fixed toshaft 1210 and spring 1279 acts against bearing 1245, which is axiallyfixed to nose tube 1218, to urge collar 1299 distally. As set forthabove, the shaft 1210 is longitudinally slideable relative to thebearing 1245 when the collet assembly 1211 is moved to lock and unlockthe cutting accessory 202, and the spring 1279 urges the shaft 1210 tomove distally with the nose tube 1218 during normal operation of thenose tube 1218.

The outer sleeve 1225 defines a hole 1275, shown in FIGS. 83 and 84,that receives the pin 1251 such that the outer sleeve 1225 and the pin1251 move together as a unit relative to the inner member 1227. Theinner member 1227 defines a slot 1277 that receives the pin 1251.

When the outer sleeve 1225 and the inner member 1227 move relative toeach other, the shaft 1210 slides longitudinally in the keyed end 1221of the inner member 1227 and the pin 1251 slides along the slot 1277. Inother words, the inner member 1227 moves relative to the outer sleeve1225, the pin 1251, and the shaft 1210. As set forth further below, tomove to the unlocked position, the shaft 1210 exerts force on the pin1251 to hold the outer sleeve 1225 in place relative to the casing 1208and the nose tube 1218 exerts force on the inner member 1227 to move theinner member 1227 relative to the outer sleeve 1225.

The outer sleeve 1225 includes a boss 1239 that rides along the arms1229. In the locked position, the boss 1239 of the outer sleeve 1225retains the feet 1235 in the slots 1233 and in the bore 1231 as shown inFIG. 88. The outer sleeve 1225 defines holes 1249 through which the arms1229/feet 1235 can extend in the unlocked position.

A spring 1247 is disposed between the outer sleeve 1225 and the innermember 1227. The spring 1247 biases the outer sleeve 1225 and the innermember 1227 toward the locked position. The spring 1247 abuts the ring1269 of the clamping member 1267 and abuts a washer 1273. The spring1247 biases the ring 1269 against a flange 1271 of the inner member 1227and biases the washer 1273 against the pin 1251, which is fixed relativeto the outer sleeve 1225.

As best shown in FIGS. 88 and 89, the cutting accessory 202 definesflats 203. To engage the cutting accessory 202 with the collet assembly1211, the outer sleeve 1225 and inner member 1227 are moved to theunlocked position such that the boss 1239 moves along the arms 1229 awayfrom the feet 1235. The cutting accessory 202 is then inserted into thebore 1231 and bias the feet 1235 out of the bore 1231 until the flats203 are aligned with the feet 1235. Feet 1235 spring back into the bore1231 when the flats 203 are aligned with the feet 1235 such that thefeet 1235 engage one of the flats 203. The inner member 1227 is thenmoved relative to the outer sleeve 1225 to the locked position to lockthe feet 1235 in engagement with the flat 203 to rotationally andtranslationally lock the cutting accessory 202 to the collet assembly1211.

The outer sleeve 1225 and inner member 1227 can be moved between thelocked position and the unlocked position by selective movement of thelead screw 1230. As set forth above, various positions within the normaloperating range of the nose tube 1218 are generally shown in FIGS.85-87. The shaft 1210 includes a flange 1241. As the nose tube 1218 isextended and retracted, the flange 1241 moves relative to the bearing1243. As shown in FIG. 87, the flange 1241 is near the bearing 1243 whenthe nose tube 1218 is nearly fully retracted. When the nose tube 1218 isfully retracted, the flange 1241 is slightly spaced from, oralternatively, in contact with, the bearing 1243.

The outer sleeve 1225 and inner member 1227 can be moved to the unlockedposition by retracting the nose tube 1218 beyond the near retractedposition of FIG. 88, i.e., beyond the predefined limit of actuation fornormal operation. When the nose tube 1218 is retracted beyond theretracted position, the flange 1241 of the shaft 1210 abuts the bearing1243 and prevents further movement of the shaft 1210 into the keyed bore1215, as shown in FIGS. 88 and 89.

As set forth above, the inner member 1227 and the nose tube 1218 aretranslationally fixed to each other and the inner member 1227 istelescopically received in the outer sleeve 1225. Spring 1247 urges theouter sleeve 1225 and the inner member 1227 such that the arms 1229 arein the locked position. When the flange 1241 abuts the bearing 1243 andthe nose tube 1218 is further retracted, the shaft 1210 prevents furthermovement of the pin 1251 and thus the outer sleeve 1225 and, as such,further retraction of the nose tube 1218 moves the inner member 1227relative to the outer sleeve 1225 thereby compressing the spring 1247,as shown in FIG. 89. In other words, the shaft 1210 abuts the pin 1251,which is fixed to the outer sleeve 1225, to prevent further movement ofthe outer sleeve 1225 while the inner member 1227 continues to move andcompress the spring 1247. As such, the inner member 1227 is movedrelative to the outer sleeve 1225 to move the arms 1229 to the unlockedposition, as set forth above, in response to actuation of the lead screwmotor 1240 beyond the predefined limit of actuation.

During normal operation, e.g., during use for a navigated surgicalprocedure, the nose tube 1218 can travel between the extended andretracted positions and does not retract beyond the retracted position.An additional step outside of the normal operation is required to engagethe cutting accessory 202 with the nose tube 1218 or disengage thecutting accessory 202 from the nose tube 1218. For example, an inputdevice (not shown) such as a button, switch, etc., can be mounted to theouter casing 1206 to provide input that allows for the nose tube 1218 tobe retracted beyond the retracted position, as set forth above, to movethe arms 1229 to the unlocked position. Alternatively, movement of thenose tube 1218 beyond the retracted position can be controlled withsoftware.

It should be appreciated that the collet assembly 1211 shown in FIGS.81-84 is shown merely for exemplary purposes and the shaft 1210 canengage the cutting accessory 202 in any suitable manner withoutdeparting from the nature of the present invention.

In another embodiment shown in FIGS. 93 and 94, the nose tube 1218 caninclude an anti-backlash device 1224 that engages the lead screw 1230and the nose tube 1218. The anti-backlash device 1224 includes an insert1246 with a threaded shoulder 1248 that threadedly engages the interiorthreads 1236 of the lead screw 1230. A coupling 1250 is fixed to thenose tube 1218 in the nose tube bore 1220. The coupling 1250 istypically fixed in the nose tube bore 1220 by press fit engagement,however, the coupling 1250 can be fixed in the nose tube bore 1220 inany suitable fashion without departing from the nature of the presentinvention. The insert 1246 and the coupling 1250 define a bore 1247 thatrotatably receives the shaft 1210. A bearing 1249 can be disposedbetween the insert 1246 and the shaft 1210.

Insert 1246 includes circumferentially spaced fingers 1252 and thecoupling 1250 includes slots 1253. The fingers 1252 and the slots 1253are engaged in alternating arrangement circumferentially about thelongitudal axis A. The fingers 1252 of the insert 1246 and the slots1253 of the coupling 1250 interlock with each other circumferentiallyabout the longitudal axis A to prevent relative rotation and slidinglyengage each other along the longitudal axis A to allow for relativetranslation along the longitudal axis A during assembly of theanti-backlash device 1224. As such, the insert 1246 can slide along thelongitudal axis A relative to the nose tube 1218.

A spring element 1254 is disposed between the insert 1246 and the nosetube 1218 and extends along the longitudal axis A between the insert1246 and the nose tube 1218. The spring element 1254 can be an O-ring ofelastomeric material, but alternatively can be any type of suitablespring element without departing from the nature of the presentinvention. The spring element 1254 exerts axial pressure on the nosetube 1218 along the longitudal axis A to bias the exterior threads 1238of the nose tube 1218 against the interior threads 1236 of the leadscrew 1230, which eliminates play between the exterior threads 1238 andinterior threads 1236 to eliminates backlash during changes inrotational direction of the lead screw 1230 relative to the nose tube1218.

As best shown in FIG. 78, the casing 1208 supports and at leastpartially encloses the rest of the distal assembly 1202 such as the nosetube 1218, lead screw 1230, lead screw motor 1240, etc. As such,adjustment of the yaw and pitch of the casing 1208, as set forth furtherbelow, also adjusts pitch and yaw of the rest of the distal assembly1202 and the cutting accessory 202 held by the distal assembly 1202.

With reference to FIG. 95, the working portion, e.g., cutting accessory202, moves about the gimbal 1258 in at least two degrees of freedomrelative to the hand-held portion 1204. Specifically, the workingportion is adjustable in pitch and yaw about the gimbal 1258. The gimbal1258 is fixed along the longitudal axis A relative to the hand-heldportion 1204. The nose tube 1218 translates relative to the gimbal 1258along longitudal axis A.

The gimbal bushing 1256 is connected to the outer casing 1206. Thegimbal 1258 is attached to the casing 1208 of the distal assembly 1202and the gimbal bushing 1256 holds the gimbal 1258 to pivotally securethe casing 1208 of the distal assembly 1202 to the outer casing 1206 ofthe proximal assembly 1204. The gimbal bushing 1256 and the gimbal 1258typically have matching inner and outer surfaces so that gimbal 1258 canpivot relative to gimbal bushing 1256. The gimbal bushing 1256 shown forexample in the Figures is split, i.e., includes two portions. The gimbalbushing 1256 is formed of a low friction material such as, for example,brass or bronze.

Gimbal 1258 is a ring shaped structure that has a frusto-sphericalshape, i.e., an outer shape of a sphere the opposed ends of which havebeen removed. The gimbal 1258 is attached to the casing 1208 of thedistal assembly 1202 so the distal assembly 1202 and the cuttingaccessory 202 are able to pivot relative to the proximal assembly 1204.The gimbal 1258 is located around the center of gravity G of distalassembly 1202 to minimize the mass moment of inertia of the distalassembly 1202 as the distal assembly 1202 is pivoted to maximize theangular acceleration for a given supplied torque.

With continued reference to FIG. 95, the gimbal 1258 defines a slot 1260and the proximal assembly 1204 includes a peg 1262 fixed to andextending from the gimbal bushing 1256 into the slot 1260. The slot 1260extends longitudinally along the gimbal 1258. The peg 1262 and the slot1260 are sized and shaped to prevent rotation of the distal assembly1202 about the longitudal axis A relative to the proximal assembly 1204while allowing pitch and yaw adjustment of the distal assembly 1202relative to the proximal assembly 1204.

The proximal assembly 1204 includes an adjustment assembly 1264 foradjusting the pitch and yaw of the distal assembly 1202 relative to theproximal assembly 1204. The proximal assembly, e.g., outer casing 1206,is held and gripped by the user. As shown in FIGS. 74-75C, the outercasing 1206 of the proximal assembly 1204 houses the adjustment assembly1264. Various views of the adjustment assembly 1264, or portionsthereof, are shown in FIGS. 97-106.

With reference to FIG. 101, adjustment assembly 1264 includes a frame1266 that houses a yaw adjustment device 1268, i.e., a yaw adjustmentmechanism 1268, and a pitch adjustment device 1270, i.e., a pitchadjustment mechanism 1270. The frame 1266 is fixed within the outercasing 1206 of the proximal assembly 1204. The yaw adjustment device1268 and the pitch adjustment device 1270 move relative to the frame1266 and engage the distal assembly 1202 to move the distal assembly1202 relative to the frame 1266 and the outer casing 1206 to adjust theyaw and pitch, respectively, of the distal assembly 1202 relative to theproximal assembly 1204.

With continued reference to FIG. 101, yaw adjustment device 1268 and thepitch adjustment device 1270 each include a pair of lead screws 1272,which are threaded, and a carriage 1274 that threadedly engages the leadscrews 1272. The lead screws 1272 typically include a fine pitchedthread to prevent backdrive (see above). The components of the yawadjustment device 1268 and the pitch adjustment device 1270, e.g., thepair of lead screws 1272 and the carriage 1274, are identical to eachother and are arranged in the frame 1266. Specifically, the frame 1266extends about an axis, and the yaw adjustment device 1268 and the pitchadjustment device 1270 are spaced from each other along the axis and arerotated 90° relative to each other about the axis.

With reference to FIG. 101, lead screws 1272 of the yaw adjustmentdevice 1268 and the pitch adjustment device 1270 are rotatably engagedwith the frame 1266. Bearings 1276 are disposed between the lead screws1272 and the frame 1266 to rotatably retain the lead screws 1272 in theframe 1266. With reference to FIG. 101, lead screws 1272 each define athreaded surface 1278 and the carriage 1274 defines a pair of threadedbores 1280 for threadedly receiving the lead screws 1272. As set forthfurther below, simultaneous rotation of the pair of lead screws 1272moves the carriage 1274 along the lead screws 1272. The carriage 1272includes pockets (not numbered) for receipt of position identifiers,e.g., magnets, that communicate with position sensors, e.g., Hall-effectsensors. Such position sensors can be fixed, for example, to the frame1266. The position sensors communicate with the control system 100.

In another embodiment shown in FIGS. 105 and 106, the carriages 1274 caneach include an anti-backlash device 1282 disposed on each of the leadscrews 1272. Each anti-backlash device 1282 includes a cap 1284 thatdefines a threaded bore 1286 that threadedly engages the lead screw1272.

Cap 1284 is coupled to the lead screw 1272. The cap 1284 includescircumferentially spaced fingers 1288 spaced about the threaded bore1286. With reference to FIG. 105, the carriage 1274 definescircumferentially spaced slots 1290. The fingers 1288 and the slots 1290are engaged in alternating arrangement circumferentially about the leadscrew 1272. The fingers 1288 of the cap 1284 engage the slots 1290circumferentially about the lead screw 1272 to prevent relative rotationand slidingly engage each other axially along the lead screw 1272 toallow for relative translation along the lead screw 1272. As such, thecap 1284 can slide along and relative to the carriage 1274 axially alongthe lead screw 1272.

A spring element 1292 is disposed between the cap 1284 and the leadscrew 1272. Spring element 1292 extends axially along the lead screw1272 between the cap 1284 and the lead screw 1272. The spring element1292 can be an O-ring of elastomeric material but alternatively can beany type of suitable spring element without departing from the nature ofthe present invention. The spring element 1292 exerts pressure on thecarriage 1274 axially along the lead screw 1272 to bias the threads ofthe threaded bores 1280 of the carriage 1274 against the threads of thethreaded surface 1278 of the lead screw 1272, which limits backlashduring changes in rotational direction of the lead screws 1272 relativeto the carriage 1274.

With reference to FIG. 101, the carriages 1274 of the yaw adjustmentdevice 1268 and the pitch adjustment device 1270 each define a slot1294. The slots 1294 extend in perpendicular directions and intersect ata pocket 1296. As best shown in FIG. 96, the casing 1208 of the distalassembly 1202 includes a post 1298 that extends into the pocket 1296.

With reference to FIGS. 102 and 103, the slots 1294 are rounded orarcuate in cross-section. As best shown in FIGS. 96, 102, and 104, aconnecting member 1257 is engaged with each slot 1294 and the post 1298.Specifically, each connecting member 1257 is shaped like gimbal 1258 anddefines an opening 1259 receiving the post 1298. The post 1298, theslots 1294, and the opening 1259 of the connecting member 1257 eachtypically include a surface formed of a low friction material such as,for example, stainless steel, brass, or bronze, and is typically highlypolished. The outer surface of connecting member 1257 can pivot relativeto the arcuate inner surface of slots 1294.

With reference to FIGS. 102 and 104, the connecting members 1257 eachhave a thickness T that is less than a width W of the slots 1294 and theconnecting members 1257 each have a height H greater than the width W ofthe slots 1294. As such, the connecting members 1257 are introduced tothe slots 1294 in an orientation such that the thickness T of theconnecting member 1257 fits within the width W of the slot 1294. Theconnecting member 1257 is then rotated to the position shown in FIGS. 96and 97 to engage the connecting member 1257 in the slot 1294. Whenengaged in the opening 1259, the post 1298 prevents rotation of theconnecting member 1257 to a position of disengagement from the slots1294.

With reference to FIG. 100, a yaw motor 1302 is engaged with the leadscrews 1272 of the yaw adjustment device 1268 and a pitch motor 1304 isengaged with the lead screws 1272 of the pitch adjustment device 1270.The yaw motor 1302 and the pitch motor 1304 are connected to respectivemotor controllers 232, 234, which are connected to the power source 140shown in FIG. 1 and described above. The motor controllers 232, 234 aretypically disposed remotely from the instrument 1200.

A yaw gear set 1306 engages the yaw motor 1302 and the lead screws 1272of the yaw adjustment device 1268. A pitch gear set 1308 engages thepitch motor 1304 and the lead screws 1272 of the pitch adjustment device1270. The lead screws 1272 of the yaw adjustment device 1268 and thepitch adjustment device 1270 engages gears (not individually numbered)of the gear sets 1306, 1308, respectively, with a press-fit engagementand/or by engagement with keyed ends, e.g., hexagonally shaped ends. Theouter casing 1206 of the proximal assembly 1204 houses the yaw motor1302 and yaw gear set 1306 and houses the pitch motor 1304 and the pitchgear set 1308.

Yaw gear set 1306 is arranged to simultaneously rotate both lead screws1272 of the yaw adjustment device 1268 at the same speed and angle uponactuation of the yaw motor 1302. Pitch gear set 1308 is arranged tosimultaneously rotate both lead screws 1272 of the pitch adjustmentdevice 1270 at the same speed and angle upon actuation of the pitchmotor 1304. As such, the carriage 1274 for each respective adjustmentdevice smoothly moves along the lead screws 1272 as the lead screws 1272are rotated.

To adjust the yaw of the distal assembly 1202 relative to the proximalassembly 1204, the yaw motor 1302 rotates the yaw gear set 1306, whichin turn rotates the lead screws 1272 and moves the carriage 1274 of theyaw adjustment device 1268 relative to the frame 1266 of the adjustmentassembly 1264. As the carriage 1274 of the yaw adjustment device 1268moves relative to the frame 1266, the carriage 1274 moves the post 1298,which pivots the casing 1208 about the gimbal 1258 to adjust the yaw ofthe distal assembly 1202 and the cutting accessory 202 mounted to thedistal assembly 1202.

To adjust the pitch of the distal assembly 1202 relative to the proximalassembly 1204, the pitch motor 1304 rotates the pitch gear set 1308,which in turn rotates the lead screws 1272 and moves the carriage 1274of the pitch adjustment device 1270 relative to the frame 1266 of theadjustment assembly 1264. As the carriage 1274 of the pitch adjustmentdevice 1270 moves relative to the frame 1266, the carriage 1274 movesthe post 1298, which pivots the casing 1208 about the gimbal 1258 toadjust the pitch of the distal assembly 1202 and the cutting accessory202 mounted to the distal assembly 1202. The connecting member 1257 movealong the slot 1294 when the carriage 1274 moves the post 1298.

Yaw motor 1302 and the pitch motor 1304 can be operated simultaneouslyand/or independently to adjust the yaw and the pitch of the distalassembly 1202 relative to the proximal assembly 1204. The lead screwmotor 1240, as discussed above, can be operated simultaneously with theyaw motor 1302 and/or the pitch motor 1304 to simultaneously move thecutting accessory along the longitudal axis A and adjust the yaw and/orpitch of the distal assembly 1202 relative to the proximal assembly1204. The lead screw motor 1240 can also be operated independently fromthe yaw motor 1302 and the pitch motor 1304.

As shown in FIG. 74, at least one circuit board 1263 is mounted in theouter casing 1206. Position sensors for the longitudal axis A position(e.g., magnet 1255 and magnet sensor), yaw position, and pitch positionof the cutting accessory 202 are in communication with the circuit board1263. For example, flex circuits connect the position sensors to thecircuit board 1263.

In one embodiment, a trigger or foot pedal, or alternatively a button,(not shown) can be supported by the outer casing 1206 of the proximalassembly 1204 to power the accessory motor, i.e., to selectively supplypower to or not supply power to the cutting accessory 202. As set forthabove with respect to instrument 200, the instrument 1200 can include asensor (not identified) disposed inside the instrument 1200. The sensorgenerates a signal if the trigger is actuated and/or not actuated. Theoutput signals from the sensor are forwarded by the data connection 133to the instrument driver 130. Based on the state of this sensor signal,the instrument driver 130 applies energization signals to the drivemotor 1212 when the tip or bur head 204 of the cutting accessory 202 isin the boundary 106 of target volume 104. In the alternative to, or inaddition to the trigger or button, a foot pedal (not shown) can be incommunication with the instrument 1200 to control the drive motor 1212by providing on/off instructions to the drive motor 1212. As set forthabove, the rotational speed of the accessory 202 is also dependent uponthe position of the tip or bur head 204 of the accessory 202 relative tothe “home” position.

As set forth above, when the tip or bur head 204 of the cuttingaccessory 202 is outside of the boundary 106 of the target volume 104,the instrument driver 130 does not apply an energization signal to thedrive motor 1212 even if the trigger is actuated. The tracking andcontrol system 100 can be configured such that the instrument driver 130applies an energization signal to reduce the speed of the cuttingaccessory 202 when the tip or bur head 204 of the cutting accessory 202enters the buffer 105 of the target volume 104, which is best shown inFIG. 2.

IX. Display Screen

A display screen 1402, also referred to as display 1402, is incommunication with the surgical instrument 200, 1200 and providesinstructions to the user for proper location and orientation of thesurgical instrument 200, 1200 to locate and orientate the cuttingaccessory 202 in the work boundary 106. As set forth above, the display1402 is in communication with the navigation system for indicating theposition of the working portion relative to the work boundary 106.

As set forth above, the surgical instrument 200, 1200 adjusts theaccessory 202 about three degrees of freedom within an adjustment range(not identified in the Figures) to orientate the accessory 202 in thework boundary 106. The display screen 1402 can be selectively used bythe user. For example, the use of the display screen 1402 may berequired for applications requiring more than three degrees of freedomof tip positioning and can be optional for applications requiring threeor less degrees of freedom of tip positioning.

As set forth above, the tracking and control system 100 tracks thepositions and orientations of the anatomy and the surgical instrument1200 to keep the tip or bur head 204 of the cutting accessory 202 withinthe target volume 104. Based on the tracking of the positions andorientations of the anatomy and the surgical instrument 1200 by thetracking and control system 100, the display screen 1402 indicatesadjustments, if any, that are required to locate and orientate thehandle assembly 500 of the surgical instrument 200 or the outer casing1206 of the surgical instrument 1200 such that the work boundary 106 iswithin the adjustment range of the surgical instrument 200, 1200, i.e.,such that the surgical instrument is capable of adjusting to locate andorientate the cutting accessory 202 in the work boundary 106.

Display screen 1402 can, for example, be a liquid crystal display (LCD)monitor, a light emitting diode (LED) monitor, an organic light emittingdiode (OLED) monitor, etc., however, it is appreciated that the displayscreen 1402 can be any type of digital or analog display withoutdeparting from the nature of the present invention. The display screen1402 can be mounted to the surgical instrument 200, 1200 and, morespecifically, can be mounted to be generally along the line of vision ofthe user when viewing the cutting accessory 202, as shown in FIGS. 72and 73, for example. Alternatively, the display screen 1402 can bespaced from and independently movable relative to the surgicalinstrument 200, 1200.

Various embodiments of visual content of the display screen 1402 areshown in FIGS. 107-111. The display screen 1402 can display a targetreticle 1404 including cross-hairs 1406 and concentric circles 1408. Theintersection 1414 of the cross-hairs identifies the desired locationand/or orientation of the handle assembly 500 of surgical instrument 200or the outer casing 1206 of surgical instrument 1200.

As shown in FIGS. 108, 110, and 111, display screen 1402 can display atranslation legend 1410 and an associated translation marker 1412.Translation of the handle assembly 500 of the surgical instrument 200 orthe outer casing 1206 of surgical instrument 1200 relative to the targetvolume 104 can be mirrored by movement of the translation marker 1412 onthe display screen 1402. In other words, the translation marker 1412moves to the left on the display screen 1402 in response to translationof the handle assembly 500 or the outer casing 1206 to the right, andthe translation marker 1412 moves to the right on the display screen1402 in response to translation of the handle assembly 500 or the outercasing 1206 the left. Similarly, the translation marker 1412 moves up ordown on the display screen 1402 in response to translation of the handleassembly 500 or the outer casing 1206 down or up, respectively. As such,to properly locate the cutting accessory 202 relative to the targetvolume 104, the user translates the handle assembly 500 or the outercasing 1206 such that the intersection 1414 of the cross-hairs movestoward the translation marker 1412. It is appreciated that the scale onthe display screen 1402 can be increased or decreased. In other words,translation of the translation marker 1412 on the display screen 1402can be a different scale in comparison to actual translation of thehandle assembly 500 or outer casing 1206.

When used with the target reticle 1404, for example, the user initiallytranslates the handle assembly 500 or the outer casing 1206 left/rightand/or up/down to locate the intersection 1414 of the cross-hairs 1406at the translation marker 1412, which locates the cutting accessory 202within the work boundary 106. Depending upon the surgical procedure, thecutting accessory 202 may be powered when the handle assembly 500 orouter casing 1206 is moved such that the translation marker 1412 movesaway from the intersection 1414 of the cross-hairs 1406 but remains inthe boundary 106. Alternatively, in other surgical procedures, such asdrilling in preparation for insertion of a screw or pin, the cuttingaccessory 202 may only be powered when the intersection 1414 of thecross-hairs 1406 is aligned with the translation marker 1412 or theinner circle of the concentric circles 1408.

In some embodiments, the display screen 1402 indicates the deviation ofthe working portion relative to the home position. The translationmarker 1412 indicates the deviation of the accessory distal tip or burhead 204 from home position. In this embodiment, the user can adjust thepitch, yaw, and translation along the longitudal axis A to keep thecutting tip 204 on a path or trajectory as long as the tip or bur head204 is not beyond the adjustment envelope, i.e., not beyond theconstraints of pitch/yaw/z-axis adjustment from home position. As aresult, the user only needs to maintain the translation marker 1412within a certain range from center, which is dependent on the extent ofdeviation from home to which the instrument is capable.

As shown in FIGS. 107-109, the display screen 1402 can display anorientation legend 1416 and an associated orientation marker 1418. Theorientation legend 1416 and orientation marker 1418 display theorientation, i.e., the pitch and yaw, of the handle assembly 500 or theouter casing 1206 relative to the target volume 104. Orientation of thehandle assembly 500 or the outer casing 1206 can be schematicallymirrored by movement of the orientation marker 1418 on the displayscreen 1402. Specifically, the orientation marker 1418 moves to the leftor to the right on the display screen 1402 in response to yaw of thehandle assembly 500 or the outer casing 1206 to the right or to theleft, respectively, relative to the target volume 104. The orientationmarker 1418 moves up or down on the display screen 1402 in response topitch of the handle assembly 500 or the outer casing 1206 down or up,respectively, relative to the target volume 104. As such, to properlyorientate the cutting accessory 202 relative to the target volume 104,the user moves the handle assembly 500 or the outer casing 1206 suchthat the intersection 1414 of the cross-hairs 1406 moves toward theorientation marker 1418.

The spacing between the circles 1408 can be a non-linear representationof the angular movement required to properly orientate the proximalassembly 1204 relative to the target volume 104. For example, when theorientation marker 1418 is on the innermost ring, the required movementof the handle assembly 500 or the outer casing 1206 is 1°, when theorientation marker 1418 is on the next ring, the required movement ofthe handle assembly 500 or the outer casing 1206 is 5°, and when theorientation marker 1418 is on the next ring, the required movement ofthe handle assembly 500 or the outer casing 1206 is 25°. The valuesassociated with each ring can be adjusted.

When used with the target reticle 1404, for example, the user initiallyorientates the handle assembly 500 or the outer casing 1206 to locatethe intersection 1414 of the cross-hairs 1406 at the orientation marker1418, which orientates the cutting accessory 202 within the workboundary 106. Depending upon the surgical procedure, the cuttingaccessory 202 may be powered when the handle assembly 500 or outercasing 1206 is moved such that the orientation marker 1418 moves awayfrom the intersection 1414 of the cross-hairs 1406 but the tip or burhead 204 remains in the work boundary 106 of the target volume 104 orwithin a predetermined deviation from the boundary 106, such as when theboundary 106 is a predefined trajectory. Alternatively, in othersurgical procedures, such as drilling in preparation for insertion of ascrew or pin, the cutting accessory 202 may only be powered when theintersection 1414 of the cross-hairs 1406 is aligned with theorientation marker 1418 or the inner circle of the concentric circles1408.

With reference to FIG. 109, the target reticle 1404 can include anacceptance ring 1420. The acceptance ring 1420, which can be theinnermost of the concentric circles 1408 of the target reticle 1404, canbe of a different color and/or thickness than the other concentriccircles 1408 for identification purposes.

The acceptance ring 1420 can indicate the range of positions of the nosetube 1218 in which the cutting accessory 202 can be operated. Theacceptance ring 1420 is typically used with the orientation marker 1418.In other words, the cutting accessory 202 can be operated when theorientation marker 1418 is in the acceptance ring 1420.

The control system 100 can be configured to control the display 1402 tochange a resolution of the display 1402 as the working portionapproaches the virtual boundary. In other words, the acceptance ring1420 can, for example, change during a procedure. For example, during adrilling procedure to create a hole for a pedicle screw, the acceptablepitch and yaw position of the nose tube 1218 can change as the tip orbur head 204 of the cutting accessory 202 moves deeper into the bone,i.e., the acceptable pitch and yaw position decreases to avoid collisionbetween the nose tube 1218 and the side of the hole as the hole getsdeeper. In such a procedure, the acceptance ring 1420 can be configuredto become smaller as the tip or bur head 202 moves deeper into the bone102 to indicate that the amount of acceptable deviation in the pitch andyaw directions is decreasing.

Display screen 1402 can display a depth legend 1422 and an associateddepth marker 1424. The depth legend 1422 and the depth marker 1424display the depth of the tip or bur head 204 of the cutting accessory202 relative to the target volume 104.

In one embodiment, the depth legend 1422 includes a top limit line 1426,a bottom limit line 1428, and a middle line 1430. The top limit line1426, which is the top line on the depth legend 1422 in FIGS. 107-109,indicates the surface of the target volume 104 and the bottom limit line1428, which is the bottom line on the depth legend 1422 in FIGS. 126-128and 131, indicates the bottom of the target volume 104. In other words,the depth legend 1422 and the depth marker 1424 indicate that the tip orbur head 204 of the cutting accessory 202 is at the surface of thetarget volume 104 when the depth marker 1424 is located on the top limitline 1426. The depth legend 1422 and the depth marker 1424 indicate thatthe tip or bur head 204 of the cutting accessory 202 is at the bottom ofthe target volume 104 when the depth marker 1424 is located on thebottom limit line 1428.

In another embodiment, the middle line 1430 indicates a home position ofthe tip or bur head 204. To locate the bur head 204 of the cuttingaccessory 202 at the correct depth relative to the target volume 104,the user moves the handle assembly 500 or the outer casing 1206 suchthat the middle line 1430 of the depth legend 1422 is displayed aboutthe depth marker 1424.

As shown in FIGS. 107-109, depth legend 1422 can display an extension1432 that extends upwardly from the top limit line 1426. The extension1432 indicates the area immediately adjacent the target volume 104.

As shown in FIG. 110, the display screen 1402 can display an acceptancebar 1434, which is shown adjacent the depth legend 1422 in FIG. 110. Inthe alternative in which the top limit line 1426 indicates the surfaceof the target volume 104 and the bottom limit line 1428 indicate thebottom of the target volume 104, the acceptance bar 1434 shown in FIG.110 includes a top 1436 that indicates the surface of the target volume104 and a bottom 1438 that indicates the bottom of the target volume104.

The display screen 1402 displays a top banner 1440 and a bottom banner1442, each of which can display selected information. For example, thetop banner 1440 and/or the bottom banner 1442 can display the type ofprocedure being performed, patient information, etc. The top banner 1440and/or the bottom banner 1442 can include indicators 1444 that indicateblocked visibility of the trackers 114, 116. The indicators 1444 can becolor coded (e.g., red and green) to indicate whether visibility isestablished or not established.

Translation legend 1410/translation marker 1412, orientation legend1416/orientation marker 1418, and depth legend 1422/depth marker 1424can be independently displayed or hidden on the display screen 1402. Thetranslation marker 1412, the orientation marker 1418, and the depthmarker 1424 can each be of a different color for ease ofdifferentiation. The translation legend 1410, the orientation legend1416, and the depth legend 1422 can be colored the same color as thetranslation marker 1412, the orientation marker 1418, and the depthmarker 1424, respectively, for easy identification. In addition to or inthe alternative to color coding, the translation marker 1412, theorientation marker 1418, and the depth marker 1424 can each be adifferent symbol for ease of differentiation.

FIGS. 107-111 show various embodiments of visual content of the displayscreen 1402. The display screen 1402 shown in FIG. 109 displays theorientation legend 1416 and orientation marker 1418 and displays thedepth legend 1422 and depth marker 1424. As set forth above, to properlyorientate the cutting accessory 202 relative to the target volume 104,the user moves the handle assembly 500 or the outer casing 1206 suchthat the intersection 1414 of the cross-hairs 1406 moves toward theorientation marker 1418. As such, in the scenario shown in FIG. 107, theuser adjusts the yaw of the handle assembly 500 or outer casing 1206 tothe right and pitches the handle assembly 500 or outer casing 1206downwardly to align the intersection 1414 with the orientation marker1418. To locate the tip or bur head 204 of the cutting accessory 202 atthe correct depth relative to the target volume 104, the user moves thehandle assembly 500 or the outer casing 1206 such that the bottom line1428 of the depth legend 1422 is disposed on the depth marker 1424. Forexample, the bottom line 1428 moves toward the depth marker 1424 whendrilling into bone with a bur to create a bore for a pedicle screw orpin.

Display screen 1402 shown in FIG. 107 displays the acceptance ring 1420and as such, the cutting accessory 202 can be powered when theacceptance ring 1420 is displayed about the orientation marker 1418.Alternatively, the display screen 1402 shown in FIG. 109 does notdisplay an acceptance ring. Display screen 1402 shown in FIG. 108displays the translation legend 1410 and translation marker 1412, theorientation axis and orientation marker 1418, and the depth legend 1422and the depth marker 1424. In this scenario, the user adjusts the yaw ofthe handle assembly 500 or outer casing 1206 to the right and pitchesthe handle assembly 500 or outer casing 1206 downwardly to align theintersection 1414 with the orientation marker 1418. The user alsotranslates the handle assembly 500 or outer casing 1206 upwardly and tothe left to align the intersection 1414 with the translation marker1412. To locate the tip or bur head 204 of the cutting accessory 202 atthe correct depth relative to the target volume 104, the user moves thehandle assembly 500 or the outer casing 1206. The display screen 1402shown in FIG. 108 displays the acceptance ring 1420 and as such, thecutting accessory 202 can be powered when the acceptance ring 1420 isdisposed about the orientation marker 1418.

Display screen 1402 shown in FIG. 108 displays the translation legend1410 and translation marker 1412 and displays the depth legend 1422 anddepth marker 1424. In this scenario, the user translates the handleassembly 500 or outer casing 1206 upwardly and to the left to align theintersection 1414 with the translation marker 1412, and more preferablyalign the intersection 1414 with the translation marker 1412. As setforth above, the display screen 1402 of FIG. 110 displays an acceptancebar 1434. In FIG. 110, the user locates the tip or bur head 204 of thecutting accessory 202 at the proper depth by moving the tip or bur head204 deeper into the target volume 104 until the acceptance bar 1434 isdisplayed along the depth marker 1424.

Although not shown, it should be appreciated that display screen 1402can be blank, i.e., does not display the target reticle 1404 and doesnot include any direction legends or markers. Such an embodiment can beused for cutting applications that do not require additional guidancefrom the display screen 1420.

The display screen 1402 shown in FIG. 111 displays the translationlegend 1410 and translation marker 1412 and displays the depth legend1422 and depth marker 1424. In this scenario, the user translates thehandle assembly 500 or outer casing 1206 upwardly and to the left toalign the intersection 1414 with the translation marker 1412. Withcontinued reference to FIG. 111, the user locates the bur head 204 ofthe cutting accessory 202 at the proper depth by moving the bur head 204out of the target volume 104 until the middle line 1430 is aligned withthe depth marker 1424.

X. Surgical Procedures

Several surgical procedures can be carried out by the system 100 andinstruments 200, 1200. Some of these procedures involve the removal oftissue such as bone. Removal of bone with the instruments 200, 1200 caninclude sculpting, shaving, coring, boring, or any other method ofremoving bone, depending on the procedure and the type of cuttingaccessory 202 attached to the instrument 200, 1200. The instrument 200,1200 can be used to remove tissue in spine, knee, hip, cranium, andother procedures. These procedures may be open procedures or minimallyinvasive procedures.

During each surgical procedure, positions and/or orientations of the burhead 204 of the instrument 200, 1200 and the anatomy being treated aredynamically tracked. Representations of the bur head 204 and the anatomyare continuously shown on the displays 113, 1402 so that the surgeon isalways aware of their relative position. The position of the bur head204 is controlled by the system 100 based on the relationship of the burhead 204 to boundaries defined in the system 100, as previouslydescribed. In some cases, the boundaries define areas of the anatomy toavoid and in other cases, the boundaries define paths that the bur head204 is specifically controlled by the system 100 to traverse.

Referring to FIGS. 112A through 112D, in one procedure, the instrument200, 1200 is used to perform a spinal fusion. Spinal fusion proceduresin which the instrument 200, 1200 can be employed to remove tissueinclude, but are not limited to, an ALIF (anterior lumbar interbodyfusion), PLIF (posterior lumbar interbody fusion), TLIF (transforamenallumbar interbody fusion), DLIF (direct lateral interbody fusion), orXLIF (extreme lateral interbody fusion).

Referring to FIG. 112A, in some interbody spinal fusions, the instrument200, 1200 may be used to first cut and penetrate through bone to accessa patient's intervertebral disc 1600. For instance, posterior access tothe disc 1600 may require penetration through the lamina 1602. Dependingon the approach taken by the surgeon, total or partial removal of thelamina 1602 of a patient may be required to access the disc 1600. Inthese embodiments, the bur head 204 (e.g., tip) of the cutting accessory202 penetrates into the patient's lamina 1602 to remove all or portionsof the lamina 1602.

Still referring to FIG. 112A, once the bone has been cut away to gainaccess to the disc 1600, the instrument 200, 1200 can also perform adiscectomy by cutting away all or part of the patient's disc 1600.

In some cases, it is not required to first remove bone to perform thediscectomy. Whether bone is required to be cut to access the disc 1600depends on the surgeon's entry decision for the procedure, e.g., whetherALIF, PLIF, TLIF, DLIF, etc. The portions of the lamina 1602 and thedisc 1600 to be removed can be pre-operatively defined as boundariesstored in the system 100 to control movement of the bur head 204.

Positions and orientations of the vertebral bodies involved in theprocedure, including their end plates 1604, 1606, and the disc 1600 aretracked using navigation by attaching a tracker 1612 to each of thevertebral bodies and then matching the vertebral bodies to pre-operativeimages so that the surgeon can visualize the material being removed onthe display 113, 1402. The position and orientation of the disc 1600 canbe inferred by tracking the position and orientation of the bone aboveand below the disc 1600. Portions of bone or disc to be removed can bedisplayed in one color, while the material to remain can be displayed ina different color. The display is updated as cutting progresses to showthe material still to be removed while eliminating the material alreadyremoved. In some embodiments, each tracker includes three or more activeor passive markers 1614 for tracking movement of the vertebral bodies.

Techniques for registering pre-operative images to a patient's anatomyare well known in the surgical navigation arts. In some embodiments, atracked pointer, such as that shown in U.S. Pat. No. 7,725,162, entitled“Surgery System”, the disclosure of which is hereby incorporated byreference, is used to identify anatomical landmarks on each vertebralbody, which are then matched to the pre-operative image to register thepre-operative image to the anatomy.

Referring to FIG. 112B, bone from bone plates 1604, 1606 can also beremoved by the bur head 204 to expose bleeding spongy bone. The exposureof bleeding bone promotes bone ingrowth with bone matrix material 1608.

The surfaces of the end plates 1604, 1606 can be cut to a surgeon'sshape preference. The end plates 1604, 1606 are shaped by the bur head204 under the guidance of the tracking and control system 100 to createthe desired shapes. The desired shape is predefined as a boundary in thesystem 100 so that the bur head 204 is controlled to stay within theboundary. In some cases, the desired shape is a planar surface milledinto the end plates 1604, 1606, while in other cases, ribbed,undulating, rough, or other non-flat surfaces are preferred to furtherlock the implant 1610 (FIG. 112C) in position.

After preparing the end plates 1604, 1606, the implant 1610 ispositioned between the end plates 1604, 1606. The bone matrix material1608 can be placed in the disc space and inside the implant 1610 beforeand/or after placement of the implant 1610, depending on the type andsize of implant being used and its location. The bone matrix material1608 can include autograft or allograft materials with or without bonemorphogenetic proteins (BMPs). The bone growth matrix 1608 could beplaced into the disc space by forceps, cannula and plunger, or the like.FIG. 112C shows the implant 1610 in position with bone matrix material1608 located in the disc space anterior to the implant 1610 and insidethe implant 1610.

The implant 1610 shown has ribs 1616 defining upper and lower surfacesof the implant 1610. A boundary could be defined in the system 100 sothat the end plates 1604, 1606 are milled to provide recesses (notnumbered) to accommodate the ribs 1616 and further lock the implant 1610in position.

Referring to FIG. 112D, once the implant 1610 is positioned between theend plates 1604, 1606, the bur head 204 of the instrument 200, 1200could be used to prepare pilot holes 1618 in the pedicles. The pilotholes 1618 are created to receive pedicle screws 1620 that form part ofa screw/rod fixation system used to stabilize the implant 1610.

Separate boundaries define trajectories for the pilot holes. The system100 controls the bur head 204 to stay along the trajectories aspreviously described to accurately cut the pilot holes 1618, includingdirection and depth. The screws 1620 are placed into the pilot holes1618 with a screw driving tool (not shown). The screws 1620 are securedwith an appropriate rod 1622.

In other embodiments, such as in anterior or lateral procedures, screwsare used in conjunction with bone plates to provide fixation for theimplants.

During spinal fusion procedures, additional boundaries (not shown) canbe defined in the system 100 to indicate locations of sensitive anatomythat needs to be avoided by the bur head 204. By defining theseboundaries in the system 100, they can be avoided by navigation of theinstrument 200, 1200. When the bur head 204 approaches such boundaries,the bur head 204 can be diverted away in three degrees of freedommovement as described above. Additionally, the surgeon can visualize theboundaries defining the sensitive anatomy on the display 113, 1402. Thesensitive anatomy may include the aorta and/or vena cava of the patientor any vasculature and/or nerves of the patient.

Other spine procedures in which the instrument 200, 1200 may be employedinclude any procedures involving stenosis, vertebral body replacement,or scar tissue removal. In the spinal procedures discussed, the bone ofinterest can be accessed either with an open procedure in which thetissue in cut and laid open, or in a minimally invasive procedure inwhich the bur head 204 is placed at the site in bone through a lumen ofa guide tube, cannula or other access channel.

Referring to FIGS. 113A and 113B, another procedure that can be carriedout by the instrument 200, 1200 is femoral acetabular impingement (FAI)surgery. FAI can occur when an excess amount of bone is present on thefemoral head of a patient. The excess bone is usually located along anupper surface of the femoral head and creates a cam-shaped head. Due toits shape, i.e., non-spherical, rotation of the femoral head in anormally shaped socket results in impingement. See, for example, theimpingement shown in FIG. 113A. To alleviate this impingement, the burhead 204 of the instrument 200, 1200 removes the excess bone to create amore uniform femoral head and relieve the area of impingement. Theinstrument 200, 1200 can also be used in some embodiments to shape boneof the acetabulum or labram attached to the acetabulum if desired.

Before the FAI procedure begins, planning involves pre-operative scans,e.g., MRI or CT scans, to provide 3-D images of the femur 1640 and hip1642. These images are stored in the system 100. Boundaries defining thevolume of excess bone 1641 to be removed and/or portions of anatomy toremain (such as the acetabulum) are then defined either automatically bythe system 100 based on a dynamic simulation of hip movement or by thesurgeon. The boundaries are stored in the system 100 and later used tocontrol movement of the bur head 204 in three degrees of freedom tomaintain the desired relationship between the bur head 204 and theboundaries.

Trackers 1644 with active or passive markers 1646 are mounted to thefemur 1640 and hip 1642. The trackers 1644 may be fixed to the femur1640 and hip 1642 using bone pins inserted into bone through the skin,or other methods known to those skilled in the art.

The pre-operative images are registered to the anatomy using thetrackers 1644 and pointer as previously described so that the system 100can track movement of the bur head 204 (e.g., tip) relative to the femur1640 and the hip 1642. In particular, the position and orientation ofthe femoral head 1648 and acetabulum 1650 are tracked during theprocedure.

In a next step of the procedure, two separate access paths are createdthrough the patient's skin. One path is created for the bur head 204 ofthe instrument 200, 1200 and one path is created for an endoscope (notshown). These access paths can be provided by guide tube, cannula, orother access creation device. In certain embodiments, these accessdevices can be tracked with the system 100 by attaching a tracker (notshown) to the devices. This allows the system 100 or user to establishthe correct path to the acetabulum/hip joint.

The instrument 200, 1200 is then placed through one access path. Theinstrument 200, 1200 is operated to remove away the desired volume ofexcess bone 1641 from the femoral head 1648. The trackers 1644 are usedby the system 100 to monitor the location of the bur head 204 relativeto the femoral head 1648, acetabulum, and any defined boundariesassociated therewith. The instrument 200, 1200 is then controlled by thesystem 100 which moves the bur head 204, if necessary, to avoid tissuethat is to remain and to ensure only the cutting of material that is tobe removed. This ensures that only the desired volume of the material1641 is removed from the femoral head 1648 to relieve the impingement.

In this procedure, when bone is being removed, the hip may need to beretracted to access difficult to reach areas of the femoral head 1648.In the autonomous mode the system 100 may first prompt for moving thepatient and retracting the hip to access these other areas.

During the procedure, the surgeon can view the volume of bone on thefemoral head 1648 to be removed, which can be indicated on the display113, 1402 in a different color than the bone to remain. The display 113,1402 can also show the bone remaining to be removed relative to theboundary defining the desired final shape of the femoral head 1648. Bytracking the bur head 204, the femoral head 1648, and the acetabulum1650, the position of the bur head 204 relative to the boundary and theanatomy can be shown on the display 113, 1402 thereby giving the surgeonconfidence that a properly shaped femoral head 1648 remains after theprocedure.

A representation of the bone on the femoral head 1648 remaining to beremoved, as well as the desired final shape of the femoral head can beoverlayed onto a viewing station associated with the endoscope (notshown). In this manner, the display for the endoscope also dynamicallyshows the bone being removed along with the endoscopic views of the boneand other tissues. In this embodiment, a tracking device (not shown) isalso attached to the endoscope (not shown) so that the position andorientation of the endoscope can be determined in the same coordinatesystem as the anatomy and the instrument 200, 1200.

The system 100 can be programmed so that as bone is removed, the dynamicsimulator of hip movement estimates the amount of impingement relievedor remaining. For instance, at the start of the procedure, the amount offree rotation (i.e., rotation with no impingement) of the femoral head1648 in the acetabulum 1650 may be X degrees. As the procedureprogresses the value of X increases. This value can be displayed on thedisplay 113, 1402. The system 100 may alert the surgeon when the valueof X reaches a predetermined threshold, indicating that enough bonematerial has been removed.

In some embodiments, other materials may be removed by the bur head 204.For example, the bur head 204 can be used to debride chondral lesions orlabral, excise bony prominences and/or reshape the acetabular rim.

Referring to FIG. 114, another procedure performed by the system 100 andinstrument 200, 1200 is anterior cruciate ligament (ACL) repair. In ACLrepair, access to the knee is provided by an arthoscope (not shown) orother guide tube or cannula. The existing ACL is first removed using ashaver or other device. A graft 1651 is then created to replace theremoved ACL. Suitable grafts include a semi-tendonosis/gracilis graft orbone-tendon-bone (BTB) graft.

Prior to the ACL repair, a pre-operative image, such as an MRI or CTscan can be used to create a three dimensional model of the knee joint,including femur 1656 and tibia 1658 and ACL. Tracking devices 1660 withactive or passive markers 1662 are mounted to each of the femur 1656 andtibia 1658 using conventional methods, for purposes of trackingpositions and orientations of the femur 1656 and tibia 1658 during theprocedure and for registering the pre-operative image to the anatomy aspreviously described.

During the procedure, two tunnels or passages 1652, 1654 are made in thefemur 1656 and tibia 1658, respectively, in which the graft 1651 issecured. Traditionally, the passages 1652, 1654 are made separately fromdifferent approaches to the femur 1656 and tibia 1658, thus requiringtwo separate cutting guides. For instance, in a typical procedure, thetibia 1658 is approached from beneath the joint and the tunnel is thendrilled toward the joint. The femur 1656 is drilled by starting in thejoint and then drilling away from the joint into the femur 1656. Theinstrument 200, 1200 can be used in the same traditional manner, withoutany cutting guides.

In the embodiment of FIG. 114, boundaries can be established in thesystem 100 that define the passages 1652, 1654. By tracking thepositions of the bur head 204, femur 1656 and tibia 1658 the system 100can control movement of the bur head 204 (e.g., tip) to stay within theboundaries. Since the boundaries are tied to the anatomy, trackingmovement of anatomy also tracks movement of the boundaries.

Using the tracking and control system 100, instead of two, separate,discontinuously-created paths in the femur 1656 and tibia 1658 asdescribed above, continuously-formed passages can be created startingfrom outside of the knee joint, through the tibia 1658, into the kneejoint, and then into the femur 1656. The passages can also be createdstarting from outside of the knee joint, through the femur 1656, intothe knee joint, and then into the tibia 1658.

To facilitate continuously-formed passages, the virtual boundarydefining the passage 1652 in the femur 1656 can be aligned with thevirtual boundary defining the passage 1654 in the tibia 1658. Forinstance, the passage 1654 in the tibia 1658 can first be made and then,without removing the cutting accessory 202 from the tibia passage 1654,the virtual boundary defining the femur passage 1652 can be aligned withthe tibia passage 1654 (or its virtual boundary). This can be done bytracking the femur 1656 and the tibia 1658 and providing an indicationof the passage or boundary alignment (or misalignment) on the display113, 1402. The value of alignment can be established as degrees fromalignment or similar values that can also be displayed numerically orgraphically on the display 113, 1402. The procedure can also be carriedout by cutting first in the femur 1656 and then proceeding to the tibia1658.

When the passages 1652, 1654 are aligned, the display 113, 1402 mayprovide an audible or visual indication so that the surgeon may operatethe instrument 200, 1200 to further penetrate the bur head 204 into thefemur 1656 to complete the cutting. The surgeon continues as long as thealignment is maintained. The result is forming the passages 1652, 1654in one continuous direction without removing the bur head 204 from thefirst formed passage and without any cutting guides.

Once the passages 1652, 1654 are created, the graft 1651 is passedthrough ACL placement instruments into the passages 1652, 1654. Thegraft 1651 is then fixed inside the passages 1652, 1654 with screws,pins, or the like.

Referring to FIGS. 115A and 115B, another procedure in which the system100 and instruments 200, 1200 can be employed is the repair of focalcartilage defects. One such procedure is arthroscopic microfracturesurgery (AMS). AMS is used to repair cartilage 1670 on an articularsurface that has worn away exposing bone 1674. The exposed bone, beingon an articular surface, is often load bearing and can result in pain tothe patient. Often AMS is employed on the articular surfaces of a kneejoint, particularly, a femur 1672.

Prior to the AMS, a pre-operative image, such as an MRI or CT scan canbe used to create a three dimensional model of the femur 1672 (and tibiaif needed). Tracking devices 1676 with active or passive markers 1678are mounted to each of the femur 1672 and tibia (if tracked) usingconventional methods, for purposes of tracking the femur 1672 and tibiaduring the procedure and for registering the pre-operative image to theanatomy as previously described.

During the procedure, the worn away area of the bone 1674 andsurrounding cartilage 1670 is accessed by an arthroscope, cannula, orother guide tube placed through the skin of the patient that provides anaccess path to the worn away area of the bone 1674. The bur head 204 ofthe instrument 200, 1200 is then placed through the created access pathinto proximity of the bone 1674. The worn away area of bone 1674 is thenreshaped by the bur head 204 (e.g., tip) to smooth any rough edges ofthe remaining cartilage 1670 surrounding the bone 1674. The exposed bone1674 is also smoothed by the bur head 204 to a contour resembling thatof the original cartilage 1670 that was worn away.

A boundary can be established in the system 100 that defines thereshaped volume as shown in FIG. 115B. This volume is defined by a depthof cutting and a smooth outer edge. By tracking the positions and/ororientations of the bur head 204, femur 1672 and tibia (if tracked)during the procedure, the bur head 204 can be maintained within theboundary. Since the boundary is tied to the anatomy, tracking movementof the anatomy also tracks movement of the boundary.

Referring to FIG. 115B, once the worn away area of bone 1674 andcartilage 1670 is reshaped, an awl 1680 or other bone punching orpenetrating instrument can be placed through the access path inproximity to the bone 1674. A bur head of the awl 1680 is then pokedinto the bone 1674 in several spots to form microfractures 1681 in thebone 1674 and cause bleeding of the bone 1674. This bleeding facilitatesthe growth of a layer of material over the bone 1674 that replaces themissing cartilage to reduce pain. A separate tracking device 1682 withmarkers 1684 could be associated with the awl 1680 to track a positionof the bur head of the awl 1680. As a result, the microfractures 1681can be placed at predefined depths in the bone 1674 and at predefinedspatial locations in relation to one another to form a predefinedpattern of the microfractures 1681. In some embodiments, as analternative to the awl 1680, the bur head 204 could be replaced with asmaller diameter bur head (e.g., smaller diameter bur head similar indiameter to awl bur head) to drill a number of small holes instead ofpunching the holes with the awl 1680.

Other knee arthroplasty procedures in which the instrument 200, 1200 canbe used includes mosaicplasty to treat focal cartilage defects, otherligament repair or reconstruction, removal of bone defects, and thelike. A similar procedure employed for ACL repairs as described abovecould be employed for PCL repairs and repairs of other ligaments thatstabilize joints.

In a mosaicplasty procedure, cartilage from an undamaged area of thejoint is moved to the damaged area. So, in the focal defect describedabove, instead of AMS, the focal defect could be repaired by boring asmall hole in the femur at the focal defect with the bur head 204 andthen filling this hole with a plug of bone/cartilage from an undamagedarea. The system 100 could be used to ensure that the depth of the holeis such that when the plug from the undamaged area is placed in thehole, the cartilage surface of the plug is flush with the cartilagesurrounding the hole. The system 100 could also be used to ensure thatthe diameter of the hole is such that the plug has a predefinedinterference fit with the hole or a predefined tolerance to receivecement or other adhesive to secure the plug in position.

The system 100 and instrument 200, 1200 could also be used to millpockets in bone for purposes of receiving an implant. As shown in FIG.116, a receiver/stimulator 1700 of a cochlear implant 1702 can be placedin a pocket 1704 milled in skull bone 1706. As with the prior describedembodiments, a boundary could be established in the system 100 thatdefines the pocket 1704. The bone 1706 could be tracked along with thebur head 204 so that the bur head 204 is maintained in the boundary toonly cut the desired size and shape of pocket 1704 needed or thereceiver/stimulator 1700.

A tracker 1708 with markers 1710 could be mounted to the bone 1706 forpurposes of tracking the bone 1706 with the system 100 and forregistering the bone 1706 to pre-operative MRI or CT scans taken of thebone 1706. By tracking the positions of the bur head 204 and bone 1706during the procedure, the bur head 204 can be maintained within theboundary. Since the boundary is tied to the anatomy, tracking movementof the anatomy also tracks movement of the boundary.

Pockets could also be created with the instrument 200, 1200 for othertypes of implants including neurostimulators, deep brain stimulators,and the like.

Rotating speed control of the bur head 204 may be employed in certainsurgical procedures when cutting tissue such as bone. For instance, inthe FAI procedure described above, the bur head 204 (e.g. bur head) maybe controlled by the system 100 so that the speed of the bur head 204 isreduced as the bur head 204 approaches the acetabulum. Furthermore, thespeed of the bur head 204 can be reduced as the bur head 204 approachessensitive anatomical tissue. In yet other embodiments, the rotatingspeed may not be affected until the bur head 204 deviates from the homeposition.

Therefore, it is an object of the intended claims to cover all suchmodifications and variations that come within the true spirit and scopeof this invention.

What is claimed is:
 1. A method of performing a minimally invasiveprocedure on a hip joint of a patient to relieve a femoral acetabularimpingement using an instrument having a hand-held portion, a cuttingaccessory defining a rotational axis, a drive motor for rotating thecutting accessory, and a separate motor for moving the cutting accessorylongitudinally relative to the hand-held portion, said method comprisingthe steps of: placing an access device through skin of the patient toprovide minimally invasive access to a target volume of material thatcreates the femoral acetabular impingement; manually grasping andsupporting the hand-held portion of the instrument to place the cuttingaccessory into the access device; removing material with the cuttingaccessory to relieve the femoral acetabular impingement while manuallygrasping and supporting the hand-held portion of the instrument; andoperating a tracking and control system to: establish a virtual boundarythat defines the target volume of material that creates the femoralacetabular impingement; track a position of the cutting accessoryrelative to the virtual boundary; and control movement of the cuttingaccessory longitudinally along the rotational axis relative to thehand-held portion so that cutting is substantially maintained within thevirtual boundary.
 2. A method as set forth in claim 1 wherein operatingthe tracking and control system to control movement of the cuttingaccessory longitudinally along the rotational axis relative to thehand-held portion includes operating the tracking and control system tocontrol longitudinal movement of the cutting accessory relative to thehand-held portion based on the position of the cutting accessoryrelative to the virtual boundary to substantially maintain a cuttinghead of the cutting accessory within the virtual boundary.
 3. A methodas set forth in claim 1 wherein operating the tracking and controlsystem to control movement of the cutting accessory longitudinally alongthe rotational axis relative to the hand-held portion includes operatingthe tracking and control system to control extension and retraction ofthe cutting accessory relative to the hand-held portion.
 4. A method asset forth in claim 1 including operating the tracking and control systemto control pitch and yaw movement of the cutting accessory relative tothe hand-held portion based on the position of the cutting accessoryrelative to the virtual boundary to substantially maintain a cuttinghead of the cutting accessory within the virtual boundary.
 5. A methodas set forth in claim 1 including operating the tracking and controlsystem to control a rotational speed of the cutting accessory based onthe position of the cutting accessory relative to the virtual boundary.6. A method as set forth in claim 1 including operating the tracking andcontrol system to attenuate a rotational speed of the cutting accessoryas the hand-held portion is moved relative to the virtual boundary so asto position the cutting accessory in proximity to the virtual boundary.7. A method as set forth in claim 1 including attaching one or moretracking devices to the patient and registering the virtual boundary tothe patient to track movement of the virtual boundary while removing thematerial with the cutting accessory.
 8. A method as set forth in claim 7wherein attaching one or more tracking devices to the patient includesattaching a first tracker to the femur and attaching a second tracker tothe hip.
 9. A method as set forth in claim 1 including viewing on adisplay the position of the cutting accessory relative to the virtualboundary.
 10. A method as set forth in claim 1 including viewing on adisplay material to be removed by the cutting accessory and material toremain after cutting, wherein the material to be removed is displayed ina different color than the material to remain after cutting.
 11. Amethod as set forth in claim 1 including retracting the hip joint of thepatient to access the target volume of material that creates the femoralacetabular impingement.
 12. A method as set forth in claim 1 whereinremoving the material includes removing material from a femur of thepatient.
 13. A method as set forth in claim 1 wherein removing thematerial includes removing material from an acetabulum of the patient.14. A method as set forth in claim 1 wherein removing the materialincludes removing material from a labram of the patient.
 15. A method asset forth in claim 1 wherein placing the access device through skin ofthe patient includes placing a guide tube through the skin.
 16. A methodas set forth in claim 1 including placing a second access device throughthe skin of the patient to provide a second minimally invasive access tothe target volume of the material.
 17. A method as set forth in claim 1including monitoring an amount of impingement relieved by removing thematerial.
 18. A method as set forth in claim 17 wherein monitoring theamount of impingement relieved by removing the material includes viewingon a display the amount of impingement relieved by removing thematerial.
 19. A method as set forth in claim 17 wherein monitoring theamount of impingement relieved by removing the material includes viewingon the display a percentage of impingement relieved by removing thematerial.
 20. A method as set forth in claim 17 including alerting auser when the amount of impingement relieved by removing the materialreaches a predetermined threshold.